List of Figures and Tables - SRJC
National Clinical Guidelines for Safe Conception and Infertility2019National Department of Health Library Cataloguing-in-Publication DataNational Guidelines for Safe Conception and FertilityISBNPublished by the National Department of Health, Republic of South Africa, 2019 Civitas Building, 222 Thabo Sehume St.,CBD Pretoria, 0001012 395 8000 clinical guidelines on safe conception and infertility responds to the National Health Insurance (NHI) principle of universal access, to promote, protect and ensure the full and equal enjoyment of all human rights and fundamental freedoms by all including persons with disabilities, and to promote respect for their inherent dignity. The guideline also addresses the needs of the lesbian, gay, bisexual transgendered and intersex, (LGBTQI) population in the context of their reproductive rights that has been lacking. Currently, the demand for services to help these communities to build a family is on the rise. This requires an adequate and right- based response. The guideline is intended to present an approach to prevention, management and psychosocial care of people seeking infertility treatment, and seeks to fill the clinical and policy gap in South Africa, as outlined in the 2019 Integrated Sexual and Reproductive Health Policy. In South Africa 1 in 6 couples experience some form of infertility [(Copper D, Morroni C, Orner P, et al, 2004)]. These guidelines provide guidance to all fertility clinic staff - doctors, nurses, midwives, counsellors, social workers, psychologists, embryologists, and administrative personnel -, who have contact with patients and make decisions regarding their care, and can deliver routine fertility care and/or make referrals to specialist care. It also allows advocacy groups and other stakeholders to address various myths and misconceptions and the infertility challenge The Fertility services should be accessible including information, diagnosis, assessment, and comprehensive fertility services. These guidelines will offer best practice and evidence based management and care of people with infertility in South Africa. It will provide recommendations for holistic care for infertility including prevention, evaluation, treatment, and psychological care. Ms MP MatsosoDirector-General: HealthOctober 2019Table of Contents TOC \o "1-3" \h \z \u List of Figures and Tables PAGEREF _Toc12031758 \h ivAcronyms PAGEREF _Toc12031759 \h vDefinitions of Terms PAGEREF _Toc12031760 \h viPreamble PAGEREF _Toc12031761 \h 1Section 1. Introduction PAGEREF _Toc12031762 \h 21.1 Purpose and scope PAGEREF _Toc12031763 \h 3Section 2. Safe conception care PAGEREF _Toc12031764 \h 42.1 Preconception Care PAGEREF _Toc12031765 \h 42.2 Preconception care for people living with HIV: Risk reduction PAGEREF _Toc12031766 \h 52.3 Prevention of infertility PAGEREF _Toc12031767 \h 5Section 3. Diagnosis and evaluation PAGEREF _Toc12031768 \h 73.1 When to evaluate? PAGEREF _Toc12031769 \h 73.2 Who should provide fertility services PAGEREF _Toc12031770 \h 73.3 Levels of care PAGEREF _Toc12031771 \h 83.4 Referral routes PAGEREF _Toc12031772 \h 103.5 Evaluation and investigations of an infertile female PAGEREF _Toc12031773 \h 103.6 Investigations to evaluate an infertile male PAGEREF _Toc12031774 \h 133.7 Investigation for infections PAGEREF _Toc12031775 \h 14Section 4. Genetic screening PAGEREF _Toc12031776 \h 15Section 5. Counselling and psychological support PAGEREF _Toc12031777 \h 165.1 Psychological impact of infertility PAGEREF _Toc12031778 \h 16Section 6. Causes of infertility and treatment options PAGEREF _Toc12031779 \h 176.1 Female factor infertility PAGEREF _Toc12031780 \h 176.2 Male factor infertility PAGEREF _Toc12031781 \h 226.3 Unexplained infertility PAGEREF _Toc12031782 \h 256.4 Safe conception for people living with HIV PAGEREF _Toc12031783 \h 256.5 Fertility treatment for single person or LGBTQI PAGEREF _Toc12031784 \h 286.6 Fertility treatment for the medically complicated persons PAGEREF _Toc12031785 \h 28Section 7. Assisted reproductive technology (ART) PAGEREF _Toc12031786 \h 30Section 8. Reproductive laboratory PAGEREF _Toc12031787 \h 328.1 Introduction PAGEREF _Toc12031788 \h 328.2 Operational requirements PAGEREF _Toc12031789 \h 338.3 Spermatology PAGEREF _Toc12031790 \h 358.4 Embryology PAGEREF _Toc12031791 \h 358.5 Standard operating procedures PAGEREF _Toc12031792 \h 37Section 9. Service delivery platform PAGEREF _Toc12031793 \h 38Addendum PAGEREF _Toc12031794 \h 40Acknowledgements PAGEREF _Toc12031795 \h 44References PAGEREF _Toc12031796 \h 45List of Figures and Tables TOC \h \z \c "Figure" Figure 1. WHO recommendations for folic acid supplementation PAGEREF _Toc12031797 \h 5Figure 2. Referral routes for different levels of care PAGEREF _Toc12031798 \h 10Figure 3. Basic fertility workup PAGEREF _Toc12031799 \h 11Figure 4. Recommended genetic testing PAGEREF _Toc12031800 \h 15Figure 5. Causes of infertility PAGEREF _Toc12031801 \h 17Figure 6. Schematic representation of causes of female factor infertility PAGEREF _Toc12031802 \h 18Figure 7. Schematic representation of the number of primordial follicles present in the ovaries and the chromosomal quality of oocytes in relation to female age and corresponding reproductive events PAGEREF _Toc12031803 \h 18Figure 8. Algorithm for the management of tubal factor infertility PAGEREF _Toc12031804 \h 20Figure 9. Algorithm for the approach to male factor infertility PAGEREF _Toc12031805 \h 24Figure 10. Standard of care for single and LGBTQI persons PAGEREF _Toc12031806 \h 28Figure 11. Algorithm for selection of laboratory procedures PAGEREF _Toc12031807 \h 32Figure 12. Overview of embryo evaluation timepoints PAGEREF _Toc12031808 \h 36 TOC \h \z \c "Table" Table 1. Evidence based lifestyle factors that affect fertility9 PAGEREF _Toc12031813 \h 6Table 2. When to evaluate persons for infertility PAGEREF _Toc12031814 \h 7Table 3. Package of services according to the levels of care PAGEREF _Toc12031815 \h 8Table 4. Services to be provided according to levels of care PAGEREF _Toc12031816 \h 9Table 5. WHO reference values for semen characteristics PAGEREF _Toc12031817 \h 13Table 6. WHO classification of ovulatory disorder and management PAGEREF _Toc12031818 \h 19Table 7. Surgery to improve female fertility and levels of care PAGEREF _Toc12031819 \h 21Table 8. Reproductive options for people living with HIV PAGEREF _Toc12031820 \h 28Table 9. ART procedures PAGEREF _Toc12031821 \h 30Table 10. Minimum staff and equipment requirements for ART procedures PAGEREF _Toc12031822 \h 33Table 11. Minimum staffing and equipment requirements at specialised fertility units PAGEREF _Toc12031823 \h 38Table 12. Minimum staffing and equipment requirements at level 2/3 infertility units PAGEREF _Toc12031824 \h 39Table 13. Example of equipment used in ART laboratory, with proposed maintenance and quality control schedule PAGEREF _Toc12031825 \h 40Table 14. Sperm preparation technique PAGEREF _Toc12031826 \h 41Table 15. Summary of critical elements during embryo culture PAGEREF _Toc12031827 \h 43AcronymsAFCAntral follicle countAMHAnti-Mullerian Hormone ARTAssisted reproductive technologiesARVAntiretroviral BBVBlood borne virusesBMIBody mass indexCASAComputer Assisted Sperm Analyzer ESGEEuropean Society of Gynecological EndoscopyESHREEuropean Society of Human Reproduction and Embryology ETEmbryo transferFSHFollicle stimulating hormoneGIFTGamete intrafallopian transferHAARTHighly active antiretroviral therapy HCGHuman chorionic gonadotropinHEPAHigh efficiency particulate air HIVHuman immunodeficiency virusHSGHysterosalpingography ICMARTInternational Committee for Monitoring Assisted Reproductive Technologies ICSIIntracytoplasmic sperm injection IUIIntrauterine inseminationIVFIn vitro fertilizationLGBTQILesbian, gay, bisexual, transgender, queer and intersexLHLuteinizing hormoneNTDNeural tube defectsOHSSOvarian hyperstimulation syndrome PCOSpolycystic ovary syndrome PGTPreimplantation genetic testing PIDPelvic inflammatory diseasePMTCTPrevention of mother-to-child transmissionSAHIVCSSouthern African HIV Clinicians SocietySTISexually transmitted infectionTBTuberculosisTESA/TESETesticular sperm aspiration/extraction TSHThyroid stimulating hormoneUAEUterine Artery Embolisation VLViral loadWHOWorld Health OrganizationDefinitions of TermsAn internationally accepted glossary of terms is adopted to ensure consistency and universal communication as recommended by the International Committee for Monitoring Assisted Reproductive Technologies (ICMART).PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5aZWdlcnMtSG9jaHNjaGlsZDwvQXV0aG9yPjxZZWFyPjIw
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ADDIN EN.CITE.DATA 1TermDefinitionAneuploidy An abnormal number of chromosomes in a cell. The majority of embryos with aneuploidies are not compatible with life.Assisted Reproductive Technology (ART)All interventions that include the in vitro handling of both human oocytes and sperm, or of embryos, for the purpose of reproduction. This includes, but is not limited to, in vitro fertilization (IVF), embryo transfer (ET), intracytoplasmic sperm injection (ICSI), embryo biopsy, preimplantation genetic testing (PGT), assisted hatching, gamete intrafallopian transfer (GIFT), zygote intrafallopian transfer, gamete and embryo cryopreservation, semen, oocyte and embryo donation, and gestational carrier cycles. AsthenoteratozoospermiaReduced percentages of motile and morphologically normal sperm in the ejaculate below the lower reference limit.AsthenozoospermiaReduced percentage of motile sperm in the ejaculate below the lower reference limit.AzoospermiaThe absence of spermatozoa in the ejaculate.Cryopreservation The process of slow freezing or vitrification to preserve biological material (e.g. gametes, zygotes, cleavage-stage embryos, blastocysts, or gonadal tissue) at extreme low temperature.FecundabilityThe probability of a pregnancy, during a single menstrual cycle in a woman with adequate exposure to sperm and no contraception, culminating in a live birth. In population-based studies, fecundability is frequently measured as the monthly probability.FecundityClinically defined as the capacity to have a live birth.Hypogonadotropic hypogonadismGonadal failure associated with reduced gametogenesis and reduced gonadal steroid production due to reduced gonadotropin production or action.InfertilityDisease characterized by the failure to establish a clinical pregnancy after 12 months of regular, unprotected sexual intercourse or due to an impairment of a person's capacity to reproduce either as an individual or with his/her partner. Fertility interventions may be initiated in less than 1 year based on medical, sexual and reproductive history, age, physical findings, and diagnostic testing.Infertility is a disease, which generates disability as an impairment of function.Intracytoplasmic sperm injection (ICSI)A procedure in which a single spermatozoon is injected into the oocyte cytoplasm.Obstructive azoospermiaAbsence of spermatozoa in the ejaculate due to occlusion of the ductal system.OligospermiaA term for low semen volume now replaced by hypospermia to avoid confusion with oligozoospermia.OligozoospermiaLow concentration of spermatozoa in the ejaculate below the lower reference limit.Oocyte The female gamete (egg).Ovarian hyperstimulation syndrome (OHSS) An exaggerated systemic response to ovarian stimulation. It may be classified as mild, moderate, or severe according to the degree of abdominal distension, ovarian enlargement, and respiratory, hemodynamic and metabolic complications.Ovarian reserve A term generally used to indicate the number and/or quality of oocytes, reflecting the ability to reproduce.Ovulation The natural process of expulsion of a mature egg from its ovarian follicle.Primary childlessness (Primary infertility)A condition in which a person has never delivered a live child, or has never been a legal or societally-recognized parent to a child.Primary female infertilityA woman who has never been diagnosed with a clinical pregnancy and meets the criteria of being classified as having infertility.Primary male infertilityA man who has never initiated a clinical pregnancy and meets the criteria of being classified as infertile.Secondary involuntary childlessness (Secondary infertility)A condition in a person with a child wish, who has previously delivered a live child, or is or has been a legal or societally-recognized parent to a child. A major cause of secondary involuntary childlessness is infertility.Secondary female infertilityA woman unable to establish a clinical pregnancy but who has previously been diagnosed with a clinical pregnancy.Secondary male infertilityA man who is unable to initiate a clinical pregnancy, but who had previously initiated a clinical pregnancy.Semen analysis A description of the ejaculate to assess function of the male reproductive tract. Characteristic parameters include volume, pH, concentration, motility, vitality, morphology of spermatozoa, and presence of other cells.SubfertilityA term that should be used interchangeably with infertility.Testicular sperm aspiration/extraction (TESA/TESE) A surgical procedure involving one or more testicular biopsies or needle aspirations to obtain sperm for use in IVF and/or ICSI.Unexplained infertilityInfertility in couples with apparently normal ovarian function, fallopian tubes, uterus, cervix, and pelvis and with adequate coital frequency; and apparently normal testicular function, genito-urinary anatomy, and a normal ejaculate. The potential for this diagnosis is dependent upon the methodologies used and/or those methodologies available.VaricocoeleA venous enlargement in the testicular pampiniform plexus.PreambleThe problem of infertility has long been identified as a priority by clinicians in South Africa. To date, it has not been defined as a disease by the policy makers in South Africa in accordance with the World Health Organisation (WHO) definition. This has resulted in services that are inaccessible, scarcely available, and at prohibitive costs. At the time of going to press, there are only two public sector hospitals that offer the full range of fertility treatment, with two additional public hospitals offering services in a public-private partnership agreement with private clinics. These guidelines seek to fill the clinical and policy gap in South Africa, where the policy component is outlined in the 2019 Integrated Sexual and Reproductive Health Policy for South Africa.IntroductionThe WHO has defined infertility as a “disease of the reproductive system”, resulting in a disability. ADDIN EN.CITE <EndNote><Cite><Author>Mascarenhas</Author><Year>2012</Year><RecNum>257</RecNum><DisplayText><style face="superscript">2</style></DisplayText><record><rec-number>257</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553667081">257</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mascarenhas, Maya N.</author><author>Flaxman, Seth R.</author><author>Boerma, Ties</author><author>Vanderpoel, Sheryl</author><author>Stevens, Gretchen A.</author></authors></contributors><titles><title>National, Regional, and Global Trends in Infertility Prevalence Since 1990: A Systematic Analysis of 277 Health Surveys</title><secondary-title>PLOS Medicine</secondary-title></titles><periodical><full-title>PLoS Med</full-title><abbr-1>PLoS medicine</abbr-1></periodical><pages>e1001356</pages><volume>9</volume><number>12</number><dates><year>2012</year></dates><publisher>Public Library of Science</publisher><urls><related-urls><url> is a global problem which transcends race, religion, culture, class, and economic status. It has an impact on the couple’s psychological, financial, medical, and social wellbeing. People affected by this disease have higher rates of depression, anxiety, suicide, divorces, intimate partner violence, and societal stigma. It should be classified as a disability and should be protected under the United Nations Convention on the Rights of Persons with Disabilities, adopted in 2006, whose purpose was to “promote, protect and ensure the full and equal enjoyment of all human rights and fundamental freedoms by all persons with disabilities, and to promote respect for their inherent dignity”. ADDIN EN.CITE <EndNote><Cite><Year>2006</Year><RecNum>258</RecNum><DisplayText><style face="superscript">3</style></DisplayText><record><rec-number>258</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553667302">258</key></foreign-keys><ref-type name="Generic">13</ref-type><contributors></contributors><titles><title>United Nations General Assembly Session 61 Resolution106. Convention on the Rights of Persons with DisabilitiesA/RES/61/106</title></titles><dates><year>2006</year></dates><urls></urls><access-date>10 November 2017</access-date></record></Cite></EndNote>3The burden of the disease worldwide is high. It is estimated that 34 million women, predominantly from developing countries are infertile, and infertility in women is ranked the fifth highest serious global disability. ADDIN EN.CITE <EndNote><Cite><Author>World Health Organization</Author><RecNum>259</RecNum><DisplayText><style face="superscript">4</style></DisplayText><record><rec-number>259</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553667467">259</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>World Health Organization,</author></authors></contributors><titles><title>World report on disability</title></titles><dates></dates><urls><related-urls><url> November 2017</access-date></record></Cite></EndNote>4 In South Africa 1 in 6 couples experience some form of infertility [REF]. The estimates of prevalence are not very accurate due to the fact that some cases are not reported.The needs of the lesbian, gay, bisexual, transgender, and intersex (LGBTQI) population in the context of their reproductive rights, has been lacking. Currently the demand for services to help this community to build a family is on the rise. This requires an adequate and a rights-based response from the country and the healthcare providers as a whole.Assisted reproduction technologies (ART) have been developed to assist infertile couples to achieve a pregnancy and to become parents.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdGVwdG9lPC9BdXRob3I+PFllYXI+MTk3NjwvWWVhcj48
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ADDIN EN.CITE.DATA 5, 6 Through the widespread global usage of ART, an estimated eight million pregnancies have been achieved worldwide [REF]. However, access to these services still remains a challenge, largely due to a lack of awareness, availability of treatment, and prohibitive costs. The social stigma associated with the problem of infertility is an added barrier for couples, preventing them from seeking help. Compounded by various myths and misconceptions, the infertility challenge is both of epidemiological and social nature. Fertility services should be accessible including information, diagnosis, assessment, and comprehensive fertility services.Purpose and scopeWhy this guidance has been producedThese guidelines present an approach to prevention, management, and psychosocial care of people seeking infertility treatment. The purpose is to provide uniformity and standardisation of care of an infertile patient to provide highly effective and cost-effective treatment.Target usersThese guidelines provide guidance to all fertility clinic staff - doctors, nurses, midwives, counsellors, social workers, psychologists, embryologists, and administrative personnel - who have contact with patients and make decisions regarding their care, and can deliver routine fertility care and/or make referrals to specialist care. They should offer a basis for advocacy by the advocacy groups and other concerned government departments in an effort to create a social and medical cohesion amongst all the stakeholders.Scope of the guidelinesThese guidelines will offer best practice and evidence based management and care of people with infertility in South Africa. They provide recommendations for holistic care for infertility including prevention, evaluation, treatment, and psychological care. Safe conception careSafe conception care recognises the importance of preserving fertility as well as providing preconception care. Family planning should take a holistic reproductive life-span approach, rather than focusing only on contraception. Patients should be counselled not only about prevention of pregnancy, but also how to prevent infertility. This will reduce the interventions needed to correct the preventable causes of infertility. The healthcare providers should use every opportunity to identify the women at risk and manage that risk appropriately.Preconception CarePreconception counselling is important to all women seeking fertility treatment in an effort to optimise the pregnancy outcomes. This should be in accordance with the WHO preconception care package of preconception care interventions. ADDIN EN.CITE <EndNote><Cite><Author>World Health Organization</Author><Year>2013</Year><RecNum>262</RecNum><DisplayText><style face="superscript">7</style></DisplayText><record><rec-number>262</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553669863">262</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>World Health Organization,</author></authors></contributors><titles><title>Preconception care: Maximizing the gains for maternal and child health. Policy Brief</title></titles><dates><year>2013</year></dates><urls></urls></record></Cite></EndNote>7Maternal age: Women over 35 years of age, who are requesting fertility treatment, should be advised of the risks of pregnancy with advanced maternal age.Folic Acid supplementation: The peri-conception period is an important time to intervene to reduce adverse pregnancy outcomes. Folic acid supplementation, before conception (at least two months) and up to 12 weeks gestation, reduces the risk of neural tube defects (NTD) in the baby. ADDIN EN.CITE <EndNote><Cite><Author>World Health Organization</Author><RecNum>263</RecNum><DisplayText><style face="superscript">8</style></DisplayText><record><rec-number>263</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553669999">263</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>World Health Organization,</author></authors></contributors><titles><title>Periconceptional folic acid supplementation to prevent neural tube defects</title></titles><dates></dates><urls><related-urls><url> REF _Ref4585957 \h \* MERGEFORMAT Figure 1 shows evidence based recommendations for folic acid supplementation.All women, from the moment they begin trying to conceive until 12 weeks of gestation, should take a folic acid supplement (400μg or 0.4mg folic acid daily). Women at high risk should: receive information on the risk of recurrence if they had a previous pregnancy with NTDbe advised on the protective effect of peri-conceptional folic acid supplementationbe offered high-dose supplementation (5 mg folic acid daily) be advised to increase their food intake of folic acidAs applied by the congenital defects guideline Identifying women at high risk of NTD’s:previous pregnancy with neural tube defectfamily history of neural tube defectswomen who take antiepileptic drugswomen who take folate antagonists (e.g. methotrexate, sulphonamides, dolutegravir)malabsorption disorders (e.g, inflammatory bowel disease)obesity with BMI > 35 kg/m2diabetesAll women, from the moment they begin trying to conceive until 12 weeks of gestation, should take a folic acid supplement (400μg or 0.4mg folic acid daily). Women at high risk should: receive information on the risk of recurrence if they had a previous pregnancy with NTDbe advised on the protective effect of peri-conceptional folic acid supplementationbe offered high-dose supplementation (5 mg folic acid daily) be advised to increase their food intake of folic acidAs applied by the congenital defects guideline Identifying women at high risk of NTD’s:previous pregnancy with neural tube defectfamily history of neural tube defectswomen who take antiepileptic drugswomen who take folate antagonists (e.g. methotrexate, sulphonamides, dolutegravir)malabsorption disorders (e.g, inflammatory bowel disease)obesity with BMI > 35 kg/m2diabetesFigure SEQ Figure \* ARABIC 1. WHO recommendations for folic acid supplementationPreconception care for people living with HIV: Risk reductionPrevent unintended pregnancyPrevent new HIV infections in women of reproductive ageOptimize maternal and paternal health with antiretroviral therapy and ensure that they are adherent to treatment and the viral load is undetectablePrevent perinatal HIV transmission (PMTCT)Prevention of infertilityPart of the history taking for all women should include their future fertility plans and to screen for lifestyle factors that may play a role in infertility. The contribution of lifestyle factors in negatively impacting on fertility is shown in REF _Ref4665980 \h \* MERGEFORMAT Table 1. Counselling should include health promoting practices and lifestyle modification. The following are evidence based prevention strategies for infertility:Safe sexual practices and prevention of sexually transmitted infection (STI) with screening for STI at every visitMaintaining a healthy weight. There is evidence that both female and male fertility are decreased by being either overweight with a body mass index (BMI) of > 25 kg/m2 or underweight with a BMI < 20 kg/m2.10Clients should be advised that fertility declines with age. Options to preserve fertility can be discussed with the healthcare providerAvoid exposure to tobacco products, illicit drugs, and excessive alcoholAvoid recreational anabolic steroids in men as this may affect semen parametersTake precautionary measures when dealing with certain environmental toxins, pesticides and other chemicalsAccess safe termination of pregnancy within the healthcare servicesTable SEQ Table \* ARABIC 1. Evidence based lifestyle factors that affect fertility ADDIN EN.CITE <EndNote><Cite><Author>Pfeifer</Author><Year>2017</Year><RecNum>264</RecNum><DisplayText><style face="superscript">9</style></DisplayText><record><rec-number>264</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553670366">264</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pfeifer, Samantha</author><author>Butts, Samantha</author><author>Fossum, Gregory</author><author>Gracia, Clarisa</author><author>La Barbera, Andrew</author><author>Mersereau, Jennifer</author><author>Odem, Randall</author><author>Paulson, Richard</author><author>Penzias, Alan</author><author>Pisarska, Margareta</author><author>Rebar, Robert</author><author>Reindollar, Richard</author><author>Rosen, Mitchell</author><author>Sandlow, Jay</author><author>Vernon, Michael</author></authors></contributors><titles><title>Optimizing natural fertility: a&#xa0;committee opinion</title><secondary-title>Fertility and Sterility</secondary-title></titles><periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></periodical><pages>52-58</pages><volume>107</volume><number>1</number><dates><year>2017</year></dates><publisher>Elsevier</publisher><isbn>0015-0282</isbn><urls><related-urls><url> that impact on fertilityObesityTime to conception increased 2-fold (if BMI ? 35)UnderweightTime to conception increased 4-fold (if BMI ? 19)SmokingRelative Risk (RR) of Infertility increased 60%AlcoholRR of Infertility increased 60% (? 2 drinks/day)CaffeineFecundability decreased 45% (? 250mg/d)Illicit drugsRR of Infertility increased 70%Toxins, solventsRR of Infertility increased 40%00Key areas:Safe conception involves preserving fertility as well as providing preconception careLife-style advice concerning extremes of bodyweight, tobacco products, excessive alcohol, and illicit drug use should be part of the counselling, as this may impact fertilityInformation on age-related infertility should be given and options discussedFolic acid supplementation should be commenced pre-pregnancySafe sexual practices are key to preventing STI’sRisk reduction measures should be taken by people living with HIVKey areas:Safe conception involves preserving fertility as well as providing preconception careLife-style advice concerning extremes of bodyweight, tobacco products, excessive alcohol, and illicit drug use should be part of the counselling, as this may impact fertilityInformation on age-related infertility should be given and options discussedFolic acid supplementation should be commenced pre-pregnancySafe sexual practices are key to preventing STI’sRisk reduction measures should be taken by people living with HIVDiagnosis and evaluationStandard of care for infertile coupleAll infertile persons should receive information on infertility causes and prevention and have treatment options discussed with them. They should be provided with appropriate diagnostic workup and receive appropriate psychological and emotional support as a basic standard of care.When to evaluate?Table SEQ Table \* ARABIC 2. When to evaluate persons for infertilityRoutine ReferralEarly ReferralImmediate ReferralAfter 1 Year of unprotected intercourseAfter 6 months of unprotected intercourseNo delayWomen 35yearsRegular cyclesNo known cause of infertility Women ≥ 35 yearsRegular cyclesNo known cause of infertilityWomen ≥ 40 yearsWomen with menstrual irregularitiesKnown cause of infertility Previous Pelvic SurgeryExposure to cytotoxic drugsStrong family history of premature Ovarian insufficiency/early menopauseSuspected endometriosisAll patients requesting tubal re-anastomosis (reversal of sterilisation)Who should provide fertility servicesTo improve the effectiveness and efficiency of treatment and satisfaction of clients, fertility care should be coordinated and mainly provided by:Gynaecologists, who will refer to fertility specialists when ART is requiredFertility SpecialistsRole of Nurses, General practitioners and Urologists:Start an initial assessment for InfertilityAssess patients prior to referral to a gynaecologistRole of Gynaecology departments in all clinics/hospitals that deliver primary fertility care:Initial assessment for InfertilitySpecialised licensed and accredited fertility clinics:Performing a complete IVF or ICSI treatment Must have highly specialized and accredited laboratories and personnelLevels of careTable SEQ Table \* ARABIC 3. Package of services according to the levels of careAssessmentComponent Service level check listLevel 1Level 2Level 3Level 4HistoryTake medical historyTake fertility historyPhysical ExaminationHormonal testingDay 2/3 FSH,LH E2(e)AMH(e)Other testsProlactin(r)TSH(r)HIV(e)Hepatitis(e)Rubella IgG(e)Syphilis serology(e)Cervical cancer screening(e)Fertility enhancement surgery(see section 8)MinorNon-specialisedMajor/specialisedSemen analysisHystero-salpingography (HSG)Intrauterine insemination (IUI)ART(r)= recommended (e) = essentialLevel 1 = Primary health care clinic, community health care centres, District hospitals, General practitioner (GP)Level 2 = Regional hospital (Gynaecologist support)Level 3 = Provincial Tertiary hospital (limited Reproductive Medicine Sub-specialist support)Level 4 = Specialised hospitals (Reproductive Medicine Sub-specialist support)Table SEQ Table \* ARABIC 4. Services to be provided according to levels of careLevels of careService providedActionLevel 1Determine:Duration of infertilityTiming of intercourseRegular cyclesAlcohol / smoking / drug useObesity / low BMIFolic Acid supplementationTests for STIs on both partners (as per STI Guidelines)HIV, Hep B S Ag, Hep C AbOffer advice or refer if:>1 year of regular unprotected intercourse in women <35 years>6 months regular unprotected intercourse in women >35 yearsKnown cause of infertilityIrregular menstrual cyclesLevel 2Baseline hormone profileUltrasound examinationHSGMinor surgical proceduresSemen analysisAnti-Mullerian Hormone (AMH) testOffer Specialist services Refer if:Blocked tubesAbnormal sperm analysis and Hormone profileSpecialised surgery to improve fertilityIf patent tubes + normal sperm analysis – advise on optimal time for sexual intercourse Level 3Major surgery Sperm processingIUI / timed intercourseGenetic screening Offer specialist services Refer if:IVF/ICSI requiredLevel 4Sperm processingSperm washingIUI/IVF/ICSISpecialised reproductive surgeryOffer sub-specialist servicesReferral routes Figure SEQ Figure \* ARABIC 2. Referral routes for different levels of careEvaluation and investigations of an infertile femaleCouples who experience problems in conceiving should be evaluated together. The importance of a couple’s approach is ensuring that no one person bears the burden or responsibility of the problem of infertility. The emphasis is placed on gender equality and collective responsibility and engagement with the health system. This inclusivity has a positive impact on the whole experience of fertility treatment. Special consideration is given to single individuals, who may be seen alone. Evaluation should be done in a cost-effective manner with a systematic approach.Basic fertility workupFigure SEQ Figure \* ARABIC 3. Basic fertility workupTest for ovarian reserveOvarian reserve denotes the reproductive potential of a woman as evidenced by oocyte number and quality. The tests for ovarian reserve may provide information on the likelihood to have a successful pregnancy. The tests do not diagnose decreased ovarian reserve but rather a possible response to ovarian stimulation.FSH, EstradiolNormal follicle stimulating hormone (FSH) levels should be less than 10 IU/L. ADDIN EN.CITE <EndNote><Cite><Year>2012</Year><RecNum>265</RecNum><DisplayText><style face="superscript">10</style></DisplayText><record><rec-number>265</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553672377">265</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><titles><title>Diagnostic evaluation of the infertile female: a committee opinion</title><secondary-title>Fertil Steril</secondary-title><alt-title>Fertility and sterility</alt-title></titles><periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></periodical><alt-periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></alt-periodical><pages>302-7</pages><volume>98</volume><number>2</number><edition>2012/06/16</edition><keywords><keyword>Advisory Committees/*standards</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Infertility, Female/*diagnosis/*therapy</keyword><keyword>Physical Examination/methods/standards</keyword><keyword>Reproductive Medicine/methods/*standards</keyword><keyword>Research Report/standards</keyword><keyword>Societies, Medical/*standards</keyword><keyword>United States</keyword></keywords><dates><year>2012</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0015-0282</isbn><accession-num>22698637</accession-num><urls></urls><electronic-resource-num>10.1016/j.fertnstert.2012.05.032</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>10 A high serum FSH level, greater than 30 to 40 IU/L with a low estradiol level, is suggestive of ovarian failure/insufficiency and is associated with poor ovarian stimulation and failure to conceive. Low or normal FSH levels, with a low estradiol levels denote hypothalamic pituitary failure and requires further evaluation. Women with abnormal FSH and estradiol levels must be referred for further evaluation.Anti-mullerian hormone (AMH) levelsWomen who are older than 35 years of age should have AMH levels tested. AMH levels are not cycle dependant and can be done on any day of the cycle. AMH levels of > 1.1ng/ml are associated with a good ovarian reserve, while an AMH of < 0.5ng/mL is associated with a reduced ovarian reserve. AMH levels between 1.0 ng/mL - 3.5ng/mL are associated with a good response to ovarian stimulation. AMH levels above 3.5 ng/mL predict a high response.PEVuZE5vdGU+PENpdGU+PFllYXI+MjAxNTwvWWVhcj48UmVjTnVtPjI2NjwvUmVjTnVtPjxEaXNw
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ADDIN EN.CITE.DATA 11, 12 In this group of patients, caution should be taken, as there is a risk of ovarian hyperstimulation syndrome. Laboratories may vary and therefore there may be variation in the AMH levels from one laboratory to another. A healthcare provider should know the reference range of the laboratory they are using.Antral Follicle Count (AFC)This is the total number of follicles in both ovaries observed with a transvaginal ultrasound in the early follicular phase measuring 2-10mm. ADDIN EN.CITE <EndNote><Cite><Year>2012</Year><RecNum>265</RecNum><DisplayText><style face="superscript">10</style></DisplayText><record><rec-number>265</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553672377">265</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><titles><title>Diagnostic evaluation of the infertile female: a committee opinion</title><secondary-title>Fertil Steril</secondary-title><alt-title>Fertility and sterility</alt-title></titles><periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></periodical><alt-periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></alt-periodical><pages>302-7</pages><volume>98</volume><number>2</number><edition>2012/06/16</edition><keywords><keyword>Advisory Committees/*standards</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Infertility, Female/*diagnosis/*therapy</keyword><keyword>Physical Examination/methods/standards</keyword><keyword>Reproductive Medicine/methods/*standards</keyword><keyword>Research Report/standards</keyword><keyword>Societies, Medical/*standards</keyword><keyword>United States</keyword></keywords><dates><year>2012</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0015-0282</isbn><accession-num>22698637</accession-num><urls></urls><electronic-resource-num>10.1016/j.fertnstert.2012.05.032</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>10 AFC of less than 6 is associated with a poor ovarian reserve. AFC is increased in women with polycystic ovary syndrome (PCOS).Other testsProlactin measurementThis test should only be offered to women who have an ovulatory disorder, suspected by irregular menstrual cycle, galactorrhoea or symptoms and signs of a pituitary tumour. It is not to be offered routinely.Thyroid function testsRoutine measurement of thyroid function should not be offered. Estimation of thyroid function should be confined to women with symptoms of thyroid disease and/or irregular menstrual cycle. Cervical cancer screeningCervical screening should be offered in accordance with the national cervical cancers screening programme guidelines. ADDIN EN.CITE <EndNote><Cite><Author>National Department of Health</Author><Year>2019</Year><RecNum>268</RecNum><DisplayText><style face="superscript">13</style></DisplayText><record><rec-number>268</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553673123">268</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>National Department of Health,</author></authors></contributors><titles><title>National Guideline for Cervical Cancer Control and Management</title></titles><dates><year>2019</year></dates><urls></urls></record></Cite></EndNote>13Investigations for tubal patencyHysterosalpingography (HSG)This test assesses tubal patency and the uterine cavity. It is the first line investigation for evaluation of tubal patency.Hysterosalpingo-contrast sonography (HyCoSy or Foam test)HyCoSy is a trans-cervical injection of echogenic contrast media and the use of ultrasound to view cavity and tubes.Laparoscopy and chromopertubationThis investigation is second line because it is invasive. It is indicated when other pathology is suspected e.g. endometriosis. Laparoscopy is not solely to assess the tube but to treat any pathology found. This should not be done routinely and not done at lower levels of care.Investigation to evaluate the uterusHysteroscopyThis is used to evaluate the uterine cavity and has an advantage of treating any pathology at time of diagnosis. (Not routinely recommended)UltrasoundUltrasound plays an important role in the workup, monitoring, and treatment of infertility. It is an indispensable tool in the management of infertility. It is readily available, non-invasive, relatively less time consuming, and easily repeatable.Investigations to evaluate an infertile maleSemen AnalysisSemen analysis should be performed and interpreted according to the 2010 WHO semen criteria as in REF _Ref4589254 \h Table 5 below. ADDIN EN.CITE <EndNote><Cite><Author>World Health Organization</Author><RecNum>269</RecNum><DisplayText><style face="superscript">14</style></DisplayText><record><rec-number>269</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553673474">269</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>World Health Organization,</author></authors></contributors><titles><title>WHO laboratory manual for the examination and processing of human semen, Fifth edition</title></titles><dates></dates><urls></urls></record></Cite></EndNote>14In case of a normal semen analysis, no repeat semen analysis should be done and no andrological tests should be performed. In case of abnormal semen analysis, a repeat semen analysis should be done and further andrological tests must be performed at the discretion of the treating physician.Table SEQ Table \* ARABIC 5. WHO reference values for semen characteristicsLower Reference limits (5th centiles and their 95% confidence intervals) for semen characteristicsAdapted from WHO laboratory manual for the examination and processing of human semen, fifth editionSpecial investigationsEndocrine EvaluationInitial hormonal evaluation should include measurement of serum FSH, luteinizing hormone (LH), Prolactin, and total testosterone (T) concentrations in cases of azoospermia or severe oligospermia. Should the initial tests be abnormal, then more extensive evaluation and referral to an endocrinologist must be considered. UltrasonographyScrotal ultrasound can helpful as an addition to physical examination and to exclude testicular tumours. Varicoceles that are not palpable clinically and only diagnosed with ultrasound are not clinically relevant. This evaluation should be done by an urologist.Post-ejaculatory urinalysisLow ejaculatory volume or absent ejaculate may indicate retrograde ejaculation. To exclude retrograde ejaculation, a post-ejaculatory urinalysis should be performed in men having an ejaculate volume is less than 1ml. ADDIN EN.CITE <EndNote><Cite><Author>Jarow</Author><Year>2002</Year><RecNum>270</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>270</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553673619">270</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Jarow, J. P.</author><author>Sharlip, I. D.</author><author>Belker, A. M.</author><author>Lipshultz, L. I.</author><author>Sigman, M.</author><author>Thomas, A. J.</author><author>Schlegel, P. N.</author><author>Howards, S. S.</author><author>Nehra, A.</author><author>Damewood, M. D.</author><author>Overstreet, J. W.</author><author>Sadovsky, R.</author></authors></contributors><titles><title>Best practice policies for male infertility</title><secondary-title>J Urol</secondary-title><alt-title>The Journal of urology</alt-title></titles><periodical><full-title>J Urol</full-title><abbr-1>The Journal of urology</abbr-1></periodical><alt-periodical><full-title>J Urol</full-title><abbr-1>The Journal of urology</abbr-1></alt-periodical><pages>2138-44</pages><volume>167</volume><number>5</number><edition>2002/04/17</edition><keywords><keyword>*Benchmarking</keyword><keyword>*Critical Pathways</keyword><keyword>*Health Policy</keyword><keyword>Humans</keyword><keyword>Infertility, Male/*diagnosis/etiology/therapy</keyword><keyword>Male</keyword><keyword>Oligospermia/diagnosis/etiology/therapy</keyword><keyword>Prognosis</keyword><keyword>Reproductive Techniques</keyword></keywords><dates><year>2002</year><pub-dates><date>May</date></pub-dates></dates><isbn>0022-5347 (Print)
0022-5347</isbn><accession-num>11956464</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>15 The urine is alkalised and post masturbation, urine is centrifuged and examined under high magnification. The presence of sperm in the post-ejaculatory urinalysis suggests retrograde ejaculation but there is no consensus about the minimum number of sperm that need to be present.Tests for anti-sperm antibodiesTests for anti-sperm antibodies are controversial and routine testing is not recommended.Testis biopsy or aspirationTestis biopsy should be considered in men with azoospermia and if spermatozoa are present, it should be frozen for the use in assisted reproduction.Investigation for infectionsHIV & HepatitisPeople undergoing IVF treatment should be offered testing for HIV, hepatitis?B, and hepatitis?C.If HIV positive, a CD4 count and a HIV viral load test must be done.Align with STI guidelines and PMTCT guidelines. ADDIN EN.CITE <EndNote><Cite><Author>South Africa National Department of Health</Author><Year>2019</Year><RecNum>271</RecNum><DisplayText><style face="superscript">16</style></DisplayText><record><rec-number>271</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553673828">271</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>South Africa National Department of Health,</author></authors></contributors><titles><title>Comprehensive STI clinical management guidelines</title></titles><dates><year>2019</year></dates><urls></urls></record></Cite></EndNote>16Rubella IgGTesting should be offered.Women who are susceptible to rubella should be offered vaccination and advised not to become pregnant for at least 1?month following vaccination.Chlamydia screeningWhere possible, STI screening and prevention should become routine and integrated into all health visits. ADDIN EN.CITE <EndNote><Cite><Author>South Africa National Department of Health</Author><Year>2019</Year><RecNum>271</RecNum><DisplayText><style face="superscript">16</style></DisplayText><record><rec-number>271</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553673828">271</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>South Africa National Department of Health,</author></authors></contributors><titles><title>Comprehensive STI clinical management guidelines</title></titles><dates><year>2019</year></dates><urls></urls></record></Cite></EndNote>16Chlamydia antibody test to detect the antibodies to Chlamydia Trachoma should not be done as its clinical utility is limited.This should align with the STI Guidelines.Genetic screeningThis should be done in accordance to the genetic screening guidelines. Routine testing is not recommended. The treating physicians should discuss and offer genetic counselling and appropriate testing.Men with non-obstructive azoospermia and severe oligozoospermia are at increased risk of having genetic and chromosomal abnormalities. ADDIN EN.CITE <EndNote><Cite><Author>Pylyp</Author><Year>2013</Year><RecNum>272</RecNum><DisplayText><style face="superscript">17</style></DisplayText><record><rec-number>272</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553674049">272</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pylyp, Larysa Y.</author><author>Spinenko, Lyudmyla O.</author><author>Verhoglyad, Natalia V.</author><author>Zukin, Valery D.</author></authors></contributors><titles><title>Chromosomal abnormalities in patients with oligozoospermia and non-obstructive azoospermia</title><secondary-title>Journal of assisted reproduction and genetics</secondary-title></titles><periodical><full-title>Journal of assisted reproduction and genetics</full-title></periodical><pages>729-732</pages><volume>30</volume><number>5</number><edition>2013/04/11</edition><dates><year>2013</year></dates><publisher>Springer US</publisher><isbn>1573-7330
1058-0468</isbn><accession-num>23575767</accession-num><urls><related-urls><url> Karyotyping must be considered in these situations. Men with congenital bilateral absence of the vas deference have a strong association with cystic fibrosis carrier status. Testing for the presence of a CFTR gene mutation should be done. Recommended algorithm for genetic testing through the stages of reproduction is shown in Figure 4 below.Testing through the stages of conceptionFigure SEQ Figure \* ARABIC 4. Recommended genetic testingKey Areas:Standard of care of infertile persons involves providing information on infertility causes and prevention and have treatment options discussed with them.Persons requesting fertility care should be provided with appropriate diagnostic workup and receive appropriate psychological and emotional support as a basic standard of care.An infertile female patient should receive a test for ovulation and a test for tubal patency as a minimum package of testing.An infertile male should receive a semen analysis as a minimum investigation.Genetic screening should be offered where appropriate.Key Areas:Standard of care of infertile persons involves providing information on infertility causes and prevention and have treatment options discussed with them.Persons requesting fertility care should be provided with appropriate diagnostic workup and receive appropriate psychological and emotional support as a basic standard of care.An infertile female patient should receive a test for ovulation and a test for tubal patency as a minimum package of testing.An infertile male should receive a semen analysis as a minimum investigation.Genetic screening should be offered where appropriate.Counselling and psychological supportPsychological impact of infertilityThere is tremendous psychological stress in people who are unable to achieve a pregnancy. In addition to the social stress and stigma, the diagnosis of infertility itself causes distress. The diagnosis and treatment of their condition is often very lengthy and cumbersome. They also have to manage the psychological stress of the knowledge that they may not achieve a pregnancy despite the extensive interventions. Some clients discontinue prematurely purely because of the burden of treatment. The stress, financial burden, and the repeated visits and investigations, which are often very invasive, have an impact on the drop-out rate of patients. In those that achieve a pregnancy, they still experience anxiety throughout the pregnancy. Providing high-quality fertility health care implies not only focusing on medical treatment for patients to achieve a successful pregnancy, but also emotionally supporting patients and healthcare providers in managing the psychological effects. The European Society of Human Reproduction and Embryology (ESHRE) Guidelines for Routine Psychosocial care in infertility and medically assisted reproduction – A guide for fertility staff, gives recommendations of psychological management of patients before, during, and after treatment. ADDIN EN.CITE <EndNote><Cite><Author>European Society of Human Reproduction and Embryology</Author><Year>2015</Year><RecNum>227</RecNum><DisplayText><style face="superscript">18</style></DisplayText><record><rec-number>227</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1542606775">227</key></foreign-keys><ref-type name="Generic">13</ref-type><contributors><authors><author>European Society of Human Reproduction and Embryology,</author></authors></contributors><titles><title>Routine psychosocial care in infertility and medically assisted reproduction – A guide for fertility staff</title></titles><dates><year>2015</year></dates><publisher>ESHRE</publisher><urls><related-urls><url> Areas:Psychological care enables couples, their families, and their healthcare providers to optimize fertility care and manage the psychological and social implications of infertility and its treatment.Infertility counselling should be undertaken by qualified and registered counsellor and/or psychologist. Patient-centred care is important as it focuses on the patient’s experience of illness and health care.Psychological management should be provided before, during, and after treatment.It is recommended that all staff coming into contact with patients have a basic understanding of the psychosocial aspects.Key Areas:Psychological care enables couples, their families, and their healthcare providers to optimize fertility care and manage the psychological and social implications of infertility and its treatment.Infertility counselling should be undertaken by qualified and registered counsellor and/or psychologist. Patient-centred care is important as it focuses on the patient’s experience of illness and health care.Psychological management should be provided before, during, and after treatment.It is recommended that all staff coming into contact with patients have a basic understanding of the psychosocial aspects.Causes of infertility and treatment optionsThe causes of infertility and their percentage contribution are depicted in REF _Ref4590618 \h Figure 5 below.Figure SEQ Figure \* ARABIC 5. Causes of infertilityFemale factor infertilityIntroductionOne third of all causes of infertility are solely due to female factors. ADDIN EN.CITE <EndNote><Cite><Author>World Health Organization</Author><RecNum>269</RecNum><DisplayText><style face="superscript">14</style></DisplayText><record><rec-number>269</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553673474">269</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>World Health Organization,</author></authors></contributors><titles><title>WHO laboratory manual for the examination and processing of human semen, Fifth edition</title></titles><dates></dates><urls></urls></record></Cite></EndNote>14 For adequate management, the contributing factors have to be identified before a treatment plan is instituted. For normal reproduction function to occur, the following factors are needed:Normal ovarian reserveRegular ovulatory cyclesPatent fallopian tubes with normal mucosal lining (at least one fallopian tube)Normal uterus and endometrial functionPatent outflow tract (uterus, cervix and vagina)Normal thyroid, pituitary gland and cerebrum functionOther factors that have a direct impact on human reproduction include the presence of endometriosis, chronic medical conditions, and adrenal gland dysfunctionCauses of female factor infertilityFigure SEQ Figure \* ARABIC 6. Schematic representation of causes of female factor infertilityOvarian factorsOvarian reserve: The quality and quantity of oocytes decline with age, resulting in a progressive decline in fertility and an increase in miscarriage rate. The ideal age to conceive is between the ages of 28 to 32 years.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Xb3JsZCBIZWFsdGggT3JnYW5pemF0aW9uPC9BdXRob3I+
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ADDIN EN.CITE.DATA 19, 20 The antral follicle count should be used to measure the ovarian reserve in all patients. The anti-mullerian hormone (AMH) should be measured in patients with endometriosis, chronic medical conditions, conditions known to affect the ovarian reserve (like Turner’s syndrome) and those above the age of 35 years.Figure SEQ Figure \* ARABIC 7. Schematic representation of the number of primordial follicles present in the ovaries and the chromosomal quality of oocytes in relation to female age and corresponding reproductive events ADDIN EN.CITE <EndNote><Cite><Author>Broekmans</Author><Year>2009</Year><RecNum>275</RecNum><DisplayText><style face="superscript">21</style></DisplayText><record><rec-number>275</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553675258">275</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Broekmans, F. J.</author><author>Soules, M. R.</author><author>Fauser, B. C.</author></authors></contributors><auth-address>Department of Reproductive Medicine and Gynecology, University Medical Center, Utrecht, The Netherlands. f.broekmans@umcutrecht.nl</auth-address><titles><title>Ovarian aging: mechanisms and clinical consequences</title><secondary-title>Endocr Rev</secondary-title><alt-title>Endocrine reviews</alt-title></titles><periodical><full-title>Endocr Rev</full-title><abbr-1>Endocrine reviews</abbr-1></periodical><alt-periodical><full-title>Endocr Rev</full-title><abbr-1>Endocrine reviews</abbr-1></alt-periodical><pages>465-93</pages><volume>30</volume><number>5</number><edition>2009/07/11</edition><keywords><keyword>Aging/*physiology</keyword><keyword>Biomarkers</keyword><keyword>Endocrine Glands/physiology</keyword><keyword>Female</keyword><keyword>Fertility/physiology</keyword><keyword>Humans</keyword><keyword>Menstrual Cycle/genetics/physiology</keyword><keyword>Oocytes/physiology</keyword><keyword>Ovary/*physiology</keyword><keyword>Pregnancy</keyword></keywords><dates><year>2009</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0163-769x</isbn><accession-num>19589949</accession-num><urls></urls><electronic-resource-num>10.1210/er.2009-0006</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>21Patients, whose ovarian reserve is reduced or very high, should be referred to and managed by reproductive medicine specialist.Ovulatory dysfunction: Ovulatory dysfunction is a major cause of infertility affecting up to 33% of patients. ADDIN EN.CITE <EndNote><Cite><Author>Wolman</Author><Year>2014</Year><RecNum>278</RecNum><DisplayText><style face="superscript">22</style></DisplayText><record><rec-number>278</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553675553">278</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Wolman, Igal</author></authors></contributors><titles><title>Berek and Novak’s Gynecology 15th Edition: Lippincott Williams and Wilkins, 2012, 1560 pp, Hardcover, Rs. 2659 on , ISBN-139788184736106, ISBN-10818473610X</title><secondary-title>Journal of Obstetrics and Gynaecology of India</secondary-title></titles><periodical><full-title>Journal of Obstetrics and Gynaecology of India</full-title></periodical><pages>150-151</pages><volume>64</volume><number>2</number><edition>2014/03/23</edition><dates><year>2014</year></dates><publisher>Springer India</publisher><isbn>0971-9202
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ADDIN EN.CITE.DATA 22, 23Group 1: Hypothalamic amenorrheaHypothalamo-hypophyseal dysfunctionAnorexia NervosaExcessive exercise (top athletes)Group 2: Hypothalamic – pituitary – ovarian dysfunctionPolycystic ovary syndrome (PCOS)Group 3: Ovarian dysfunctionTurner’s syndromePrimary ovarian insufficiencyTable SEQ Table \* ARABIC 6. WHO classification of ovulatory disorder and managementWHO group 1(Hypothalamic Amenorrhoea)WHO group 2(PCOS)WHO group 3(Ovarian dysfunction)FSH – lowLH - lowEstradiol - lowFSH – normalLH – normalEstradiol - normalFSH - HighLH – HighEstradiol - lowLifestyle managementIncrease BMI >18Reduce excessive exerciseLifestyle managementWeight reduction of at least 5 %IVF using donor eggsPsychotherapy1st line: Clomiphene citrate 25 to 150 mg daily for 5 days starting on day 3-6 of cyclesAlternatively Letrozole 2,5 – 7,5 mg dailyClomiphene citrate and Letrozole contraindicatedGonadotropins including FSH and LH2nd line:Gonadotropins or laparoscopic ovarian drilling if a person has clomiphene failure or resistance.Psychological counselling recommendedClomiphene citrate contraindicated3rd line: IVF when all other options were unsuccessfulTubal factor infertility: Blocked fallopian tubes are the most common cause of female factor infertility in South Africa.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGFybWE8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 24-27 It is most frequently caused by previous pelvic inflammatory disease (PID), endometriosis, previous pelvic surgery, or previous tubal ligation. Treatment options include assisted reproduction or tuboplasties, which are only available at certain public sector hospitals. Unfortunately, many patients cannot afford ART and tubal surgery may be the only available option for them. Tuboplasty should be offered to patients with previous tubal ligation and those with good prognosis hydrosalpinges. The tubal reconstruction surgery should be done by an experienced gynaecological surgeon. Patients with poor prognosis hydrosalpinges should also be offered tubal surgery to remove the damaged fallopian tubes as the fluid from the hydrosalpinges has been associated with poor pregnancy outcome in ART cycle.Figure SEQ Figure \* ARABIC 8. Algorithm for the management of tubal factor infertilityUterine factorsThe uterus is a major organ that can impact on reproductive outcome. Some uterine abnormalities are amenable to surgery which can improve pregnancy outcomes, some are not.Fibroids: About 1/3 of women will have fibroids. Most fibroids do not have a negative impact on reproductive outcome and thus require no treatment. Submucosal fibroids are mostly symptomatic. They cause heavy menstrual bleeding, prolonged menstrual bleeding, implantation failure, and recurrent pregnancy losses. The Submucosal fibroids, ESGE type 0, 1 and 2, should be removed preferably through hysteroscopy or laparoscopy according to the type.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYW1zdGVrZXI8L0F1dGhvcj48WWVhcj4xOTkzPC9ZZWFy
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ADDIN EN.CITE.DATA 28, 29 Large intramural fibroids that are 5cm or more in size should also be removed as they have been associated with poor reproductive outcome. Laparoscopic myomectomy is preferred over laparotomy if the doctor’s skills are adequate.Uterine artery embolisation (UAE) is available and sometimes offered to patients instead of myomectomy. There have been a number of patients who conceived after UAE. However, serious morbidity has been reported. There is a high risk of morbidly adherent placenta, miscarriage, low birth weight, intra-uterine growth restriction, preterm delivery, and post-partum haemorrhage post UAE.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ib2x1YjwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 30 Its effect on future pregnancy and fertility remains unclear. All patients who conceived after UAE require close monitoring.Uterine anomaliesSeptate Uterus: The septate uterus causes most reproductive failures. Women with a septate uterus should be referred to a reproductive medicine specialist for evaluation and assessment if hysteroscopic removal will improve fertility outcomes.Uterus Didelphus and unicornuate uterus: Patients with a double uterus (Didelphus) and those with a unicornuate should not be offered any surgery except if there is a non-communicating horn of the unicornuate uterus or functional horn that creates chronic pelvic pain.Bicornuate Uterus: The efficacy of doing metroplasty in patients with a bicornuate uterus is still not fully understood. It should not be done as a routine procedure but must be considered in patients with previous reproductive failure. It can be performed via laparoscopy or laparotomy. Asherman’s syndromeAsherman’s syndrome presents as secondary amenorrhea or hypomenorrhea. The major cause of these intrauterine adhesions is intrauterine curettage postpartum or post- abortion. Treatment of severe Asherman’s syndrome is extremely difficult. These patients should be referred to an endoscopic surgeon for hysteroscopic resection of the synechiae. In very severe cases, the patient may require the services of a surrogate. In our setting, Genital tuberculosis (TB) as a cause of severe Asherman’s syndrome should be investigated.The role of dilatation and curettage (D&C) in reproductionD&C should NEVER be used to improve the reproductive outcome of patients. It should NOT be offered to patients with heavy menstrual bleeding. Rather offer hysteroscopy for diagnostic and treatment purposes. The role of dilatation and curettage (D&C) in reproductionD&C should NEVER be used to improve the reproductive outcome of patients. It should NOT be offered to patients with heavy menstrual bleeding. Rather offer hysteroscopy for diagnostic and treatment purposes. Table SEQ Table \* ARABIC 7. Surgery to improve female fertility and levels of careMinor surgeryLevel 2/3/4Diagnostic Laparoscopy and chromopertubationSalpingectomyHysteroscopic polypectomyCervical cerclageMajor surgeryLevel 3/4OvariesCystectomyDrillingFallopian TubesReversal of sterilisationTuboplastyUterusMyomectomy (laparoscopy, hysteroscopy, laparotomy)Asherman’s SyndromeSeptum resectionMetroplastyEndometriosisKey Areas:Counselling is an important part of fertility treatmentPersons seeking fertility treatment should be advised that lifestyle modification may improve fertilityIndications for surgery must be aimed at improving fertilityThe male partner must have a semen analysis before surgery is performed on the female partner to exclude the male factorThere must be access to assisted reproduction technologiesKey Areas:Counselling is an important part of fertility treatmentPersons seeking fertility treatment should be advised that lifestyle modification may improve fertilityIndications for surgery must be aimed at improving fertilityThe male partner must have a semen analysis before surgery is performed on the female partner to exclude the male factorThere must be access to assisted reproduction technologiesMale factor infertilityTwenty percent of cases of infertility are solely due to male factor infertility, and male factory infertility contributes in 30%-40% of couples overall. ADDIN EN.CITE <EndNote><Cite><Author>Jarow</Author><Year>2002</Year><RecNum>270</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>270</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553673619">270</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Jarow, J. P.</author><author>Sharlip, I. D.</author><author>Belker, A. M.</author><author>Lipshultz, L. I.</author><author>Sigman, M.</author><author>Thomas, A. J.</author><author>Schlegel, P. N.</author><author>Howards, S. S.</author><author>Nehra, A.</author><author>Damewood, M. D.</author><author>Overstreet, J. W.</author><author>Sadovsky, R.</author></authors></contributors><titles><title>Best practice policies for male infertility</title><secondary-title>J Urol</secondary-title><alt-title>The Journal of urology</alt-title></titles><periodical><full-title>J Urol</full-title><abbr-1>The Journal of urology</abbr-1></periodical><alt-periodical><full-title>J Urol</full-title><abbr-1>The Journal of urology</abbr-1></alt-periodical><pages>2138-44</pages><volume>167</volume><number>5</number><edition>2002/04/17</edition><keywords><keyword>*Benchmarking</keyword><keyword>*Critical Pathways</keyword><keyword>*Health Policy</keyword><keyword>Humans</keyword><keyword>Infertility, Male/*diagnosis/etiology/therapy</keyword><keyword>Male</keyword><keyword>Oligospermia/diagnosis/etiology/therapy</keyword><keyword>Prognosis</keyword><keyword>Reproductive Techniques</keyword></keywords><dates><year>2002</year><pub-dates><date>May</date></pub-dates></dates><isbn>0022-5347 (Print)
0022-5347</isbn><accession-num>11956464</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>15 It is imperative that infertility not be seen as either a female or male problem but that the problem is addressed as a couple. Education of the population about male infertility is needed to eliminate the stigma around the condition and to address the reluctance of some men to be tested. The evaluation of the male must always be in parallel to the evaluation of the female. No invasive procedures like laparoscopy or myomectomy should be performed without a semen analysis on the male partner. The fact that a man has children in a previous relationship should never be a reason not to test the man.Reproductive HistoryA detailed history should include:Duration of infertility, coital frequency, and timing, as well as erectile dysfunctionPubertal development and childhood illnesses specifically enquiring about undescended testisPrevious surgery (inguinal hernia repair) Medical history such as diabetes mellitus and upper respiratory diseaseChronic medication History of sexually transmitted infections Smoking, alcohol, recreational drugs use, and anabolic steroid use Exposure to gonadotoxins (e.g. chemotherapy and radiation therapy)Physical ExaminationGeneral physical examination and examination of the genitalia must be performed. Secondary sex characteristics, including body habitus, hair distribution, and breast development should be documented. Attention should be given to penile abnormalities, the testis volume and the presence of a varicocele. In cases of azoospermia, palpation for the presence of the vas deference must be performed. Semen AnalysisSemen analysis is the most important test for the evaluation of male subfertility. A standardized instruction for semen collection is 2-3 days abstinence. ADDIN EN.CITE <EndNote><Cite><Author>Huyser</Author><Year>2017</Year><RecNum>288</RecNum><DisplayText><style face="superscript">31</style></DisplayText><record><rec-number>288</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553677925">288</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Huyser, C</author></authors></contributors><titles><title>Semen collection and sample reception. In: Rizk, B., Montag, S. eds. Standard Operational Procedures in Reproductive Medicine: Laboratory and Clinical Practice. Oxfordshire, UK: CRC Press. p 14-16.</title></titles><dates><year>2017</year></dates><urls></urls></record></Cite></EndNote>31 Semen can be collected by means of masturbation into a specimen cup or by intercourse with the use of special semen collection condoms that is not toxic to sperm. The specimen must ideally be collected at the laboratory but if collected at home it must be transported at room temperature within an hour to the laboratory. ADDIN EN.CITE <EndNote><Cite><Author>World Health Organization</Author><RecNum>269</RecNum><DisplayText><style face="superscript">14</style></DisplayText><record><rec-number>269</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553673474">269</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>World Health Organization,</author></authors></contributors><titles><title>WHO laboratory manual for the examination and processing of human semen, Fifth edition</title></titles><dates></dates><urls></urls></record></Cite></EndNote>14 The results of semen analysis conducted as part of an initial assessment should be compared with the World Health Organization reference values 2010.When the initial semen analysis is normal, no further investigation is necessary. When the semen analysis is abnormal, a second semen analysis is recommended after 6 weeks. Should the reproductive history be abnormal or the semen parameters remain abnormal evaluation by an urologist or reproductive medicine specialist is indicated.General managementCounselling should be offered before, during, and after investigation and treatment, because fertility problems can cause psychological stress and put pressure on relationships.Excessive alcohol consumption may impair semen quality.Smoking affects semen quality and may influence the chance of conception and men and women should be advised to stop smoking.Men who have a high BMI are at increased risk of infertility. ADDIN EN.CITE <EndNote><Cite><Author>Nguyen</Author><Year>2007</Year><RecNum>289</RecNum><DisplayText><style face="superscript">32</style></DisplayText><record><rec-number>289</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553678281">289</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nguyen, R. H.</author><author>Wilcox, A. J.</author><author>Skjaerven, R.</author><author>Baird, D. D.</author></authors></contributors><auth-address>National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH, DHHS), Research Triangle Park, NC, USA. nguyen5@niehs.</auth-address><titles><title>Men's body mass index and infertility</title><secondary-title>Hum Reprod</secondary-title><alt-title>Human reproduction (Oxford, England)</alt-title></titles><periodical><full-title>Hum Reprod</full-title><abbr-1>Human reproduction (Oxford, England)</abbr-1></periodical><alt-periodical><full-title>Hum Reprod</full-title><abbr-1>Human reproduction (Oxford, England)</abbr-1></alt-periodical><pages>2488-93</pages><volume>22</volume><number>9</number><edition>2007/07/20</edition><keywords><keyword>Adult</keyword><keyword>*Body Mass Index</keyword><keyword>Body Weight</keyword><keyword>Cohort Studies</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Infertility, Male/*epidemiology</keyword><keyword>Male</keyword><keyword>Norway/epidemiology</keyword><keyword>*Overweight</keyword></keywords><dates><year>2007</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>0268-1161 (Print)
0268-1161</isbn><accession-num>17636282</accession-num><urls></urls><electronic-resource-num>10.1093/humrep/dem139</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>32 ?Recreational drugs interfere with male and female fertility and use of anabolic steroids suppresses spermatogenesis.Medical managementThe use of anti-oestrogens, gonadotrophins (HCG and FSH), androgens, bromocriptine, or kinin-enhancing drugs for semen abnormalities is not recommended because there is no evidence of efficacy. Corticosteroids should not be used for antisperm antibodies.Men with hypogonadotropic hypogonadism should be treated with gonadotrophins.The use of anti-oxidant therapy may be beneficial in idiopathic semen abnormalities. Surgical managementSurgery for varicoceles may be considered when there is a clinically palpable varicocele, with abnormal semen parameters and no female factor for infertility is present. ADDIN EN.CITE <EndNote><Cite><Year>2014</Year><RecNum>290</RecNum><DisplayText><style face="superscript">33</style></DisplayText><record><rec-number>290</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553678356">290</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><titles><title>Report on varicocele and infertility: a committee opinion</title><secondary-title>Fertil Steril</secondary-title><alt-title>Fertility and sterility</alt-title></titles><periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></periodical><alt-periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></alt-periodical><pages>1556-60</pages><volume>102</volume><number>6</number><edition>2014/12/03</edition><keywords><keyword>Adult</keyword><keyword>Embolization, Therapeutic</keyword><keyword>Humans</keyword><keyword>Infertility, Male/*therapy</keyword><keyword>Male</keyword><keyword>Reproductive Techniques, Assisted</keyword><keyword>*Varicocele/diagnosis/surgery/therapy</keyword></keywords><dates><year>2014</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0015-0282</isbn><accession-num>25458620</accession-num><urls></urls><electronic-resource-num>10.1016/j.fertnstert.2014.10.007</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>33 In cases where IVF needs to be performed for female factors, surgery for varicoceles is not indicated.Vasectomy reversal should be considered in men with fertility wish after vasectomy. Female factors must first be excluded. Alternative treatment is testicular sperm extraction and IVF or ICSI. The surgery should be performed by an experienced surgeon using microsurgical technique.Assisted reproductionIntra uterine insemination (IUI) should be considered in cases of mild male factor. Maximum of 3-6 cycles should be done.Intra cytoplasmic sperm injection (ICSI) is the recommended treatment of choice for infertility due to male factor where appropriate.In cases of azoospermia surgical retrieval of sperm with ICSI should be offered.Donor sperm is used in cases where ICSI cannot be performed.Figure SEQ Figure \* ARABIC 9. Algorithm for the approach to male factor infertilityKey Areas:Counselling should be offered before, during, and after investigations and treatmentLifestyle modification can improve fertility in some casesSemen analysis is the most important test for the evaluation of male subfertilityAndrologic testing and other investigations should be done when a second semen analysis is abnormalThere should be access to assisted reproductive technologiesKey Areas:Counselling should be offered before, during, and after investigations and treatmentLifestyle modification can improve fertility in some casesSemen analysis is the most important test for the evaluation of male subfertilityAndrologic testing and other investigations should be done when a second semen analysis is abnormalThere should be access to assisted reproductive technologiesUnexplained infertilityThis is defined as infertility where the cause remains unknown after extensive and comprehensive investigations. The management of unexplained infertility should be individualised. Lifestyle modification and advice on adequate sexual intercourse and best timing of intercourse should be discussed. Other treatment modalities can then be offered according to efficacy, cost, ease of use and safety.Treatment options may include expectant management; oral ovulation induction agents, such as clomifene citrate or letrozole, with intrauterine insemination (IUI); or in vitro fertilization (IVF). IUI still remains a reasonable treatment option for unexplained infertility in the South African setting because of the lower costs and safety. It is a less invasive and less cumbersome treatment. A maximum of 3-6 cycles should be done. If there is no successful pregnancy after 3-6 cycles, the high-resource intensive treatment option of IVF should be considered. Patient selection is important and patient’s wishes should also be taken into consideration.Safe conception for people living with HIVIntroductionHuman immunodeficiency virus (HIV) infection affects people in their reproductive years. Up to 40% of those infected are 25-29 years old. ADDIN EN.CITE <EndNote><Cite><Author>Pennings G</Author><RecNum>291</RecNum><DisplayText><style face="superscript">34</style></DisplayText><record><rec-number>291</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553679504">291</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pennings G,</author></authors></contributors><titles><title>The physician as an accessory in the parental project of HIV positive people</title><secondary-title>Med Ethics</secondary-title></titles><periodical><full-title>Med Ethics</full-title></periodical><volume>2003</volume><number>321-324</number><dates></dates><urls></urls></record></Cite></EndNote>34 Often they have not yet started their families. As they establish long term relationships, the desire to start a family becomes the logical evolution in the relationship. HIV affected couples should have the same access to investigations and treatment of infertility as the unaffected couples. For HIV affected couples who have presumed normal fertility, providers have a responsibility to support the couple to conceive safely, with minimal HIV risks to ensure optimal maternal and perinatal outcomes. When couples are seroconcordant, the aim is to assist with conception without risk of superinfection and aim for unaffected offspring. When the couple is serodifferent (serodiscordant), the priority is to prevent infection of the uninfected partner while assisting with safe conception and to also aim for unaffected offspring. Deferring fertility treatments until the risks of HIV transmission have been minimised may be recommended in some situations.Ethical issuesIt is unethical to deny couples affected by HIV their right to reproductive freedom. This has been significantly revolutionized with the introduction of highly active antiretroviral therapy (HAART), with the life expectancy of people affected by HIV reaching that of non-infected people. There are ethical and psychological considerations that the treating healthcare provider must take into account when providing fertility counselling and treatment for people living with HIV. There must be a multidisciplinary approach to HIV management. There should be adequate counselling regarding safer sex practices and risk reduction measures.The fertility status of both partners and their concerns about transmission risk govern the options discussed for safer conception.The fertile period should be adequately explained and safer conception options explored if infertility is not an issue.Couples should be counselled about the available risk reduction strategies, including antiretroviral therapy and PrEP. Should they continue to have concerns about HIV risk then referral to a reproductive medicine specialist unit for further management may be considered.Healthcare providers at the relevant ARV clinics and day hospitals should receive adequate training.There is still the unintended bias toward discouraging individuals who are infected from having children. ADDIN EN.CITE <EndNote><Cite><Year>2010</Year><RecNum>292</RecNum><DisplayText><style face="superscript">35</style></DisplayText><record><rec-number>292</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553679561">292</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><titles><title>Human immunodeficiency virus and infertility treatment</title><secondary-title>Fertil Steril</secondary-title><alt-title>Fertility and sterility</alt-title></titles><periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></periodical><alt-periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></alt-periodical><pages>11-5</pages><volume>94</volume><number>1</number><edition>2010/03/20</edition><keywords><keyword>Ethics Committees, Clinical/*ethics</keyword><keyword>Female</keyword><keyword>*hiv</keyword><keyword>HIV Infections/complications/*therapy/transmission</keyword><keyword>Humans</keyword><keyword>Infectious Disease Transmission, Vertical/ethics/prevention & control</keyword><keyword>Infertility/etiology/*therapy/virology</keyword><keyword>Male</keyword><keyword>Pregnancy</keyword><keyword>Pregnancy Complications, Infectious/etiology/therapy/virology</keyword><keyword>Risk Factors</keyword><keyword>Societies, Medical/*ethics</keyword></keywords><dates><year>2010</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>0015-0282</isbn><accession-num>20236636</accession-num><urls></urls><electronic-resource-num>10.1016/j.fertnstert.2010.01.077</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>35Why fertility is compromised in people living with HIVPeople who are living with HIV often face the following issues that may compromise fertility.The consistent use of condoms in itself, while recommended, prevents pregnancy. 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ADDIN EN.CITE.DATA 38Antiretroviral treatment may cause alteration in sperm characteristics such as a decrease in ejaculate volume and percentage of motile spermatozoa. ADDIN EN.CITE <EndNote><Cite><Author>Baeten</Author><Year>2016</Year><RecNum>296</RecNum><DisplayText><style face="superscript">39</style></DisplayText><record><rec-number>296</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553679800">296</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Baeten, Jared M.</author><author>Heffron, Renee</author><author>Kidoguchi, Lara</author><author>Mugo, Nelly R.</author><author>Katabira, Elly</author><author>Bukusi, Elizabeth A.</author><author>Asiimwe, Stephen</author><author>Haberer, Jessica E.</author><author>Morton, Jennifer</author><author>Ngure, Kenneth</author><author>Bulya, Nulu</author><author>Odoyo, Josephine</author><author>Tindimwebwa, Edna</author><author>Hendrix, Craig</author><author>Marzinke, Mark A.</author><author>Ware, Norma C.</author><author>Wyatt, Monique A.</author><author>Morrison, Susan</author><author>Haugen, Harald</author><author>Mujugira, Andrew</author><author>Donnell, Deborah</author><author>Celum, Connie</author><author>Partners Demonstration Project, Team</author></authors></contributors><titles><title>Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1–Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda</title><secondary-title>PLOS Medicine</secondary-title></titles><periodical><full-title>PLoS Med</full-title><abbr-1>PLoS medicine</abbr-1></periodical><pages>e1002099</pages><volume>13</volume><number>8</number><dates><year>2016</year></dates><publisher>Public Library of Science</publisher><urls><related-urls><url> mtDNA content is depleted in oocytes of infertile HIV-infected women under HAART treatment. This mitochondrial defect in oocytes could eventually lead to cell dysfunction and infertility.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GcmFwc2F1Y2U8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFy
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ADDIN EN.CITE.DATA 41Sperm washing is also an option for safe reproduction for serodifferent couples where the male is HIV-positive. ADDIN EN.CITE <EndNote><Cite><Author>Gilling-Smith</Author><Year>2010</Year><RecNum>299</RecNum><DisplayText><style face="superscript">42</style></DisplayText><record><rec-number>299</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553736469">299</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Gilling-Smith, Carole</author><author>Vourliotis, Maria</author><author>Almeida, Paula</author><author>Goulding, Rebecca</author><author>Nicopoullos, James D. M.</author></authors></contributors><titles><title>A decade of sperm washing: clinical correlates of successful insemination outcome</title><secondary-title>Human Reproduction</secondary-title></titles><periodical><full-title>Human Reproduction</full-title></periodical><pages>1869-1876</pages><volume>25</volume><number>8</number><dates><year>2010</year></dates><isbn>0268-1161</isbn><urls><related-urls><url> HIV virus is present in semen as free virus in the seminal plasma and as cell associated virus in the non-sperm cells. There is a significant reduction in the risk of viral transmission if spermatozoa are washed free of seminal plasma and non-sperm cells. ADDIN EN.CITE <EndNote><Cite><Author>Semprini</Author><Year>1992</Year><RecNum>300</RecNum><DisplayText><style face="superscript">43</style></DisplayText><record><rec-number>300</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553736861">300</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Semprini, A. E.</author><author>Levi-Setti, P.</author><author>Bozzo, M.</author><author>Ravizza, M.</author><author>Taglioretti, A.</author><author>Sulpizio, P.</author><author>Albani, E.</author><author>Oneta, M.</author><author>Pardi, G.</author></authors></contributors><auth-address>Department of Obstetrics and Gynecology, San Paolo Biomedical Institute, University of Milan Medical School, Italy.</auth-address><titles><title>Insemination of HIV-negative women with processed semen of HIV-positive partners</title><secondary-title>Lancet</secondary-title><alt-title>Lancet (London, England)</alt-title></titles><periodical><full-title>Lancet</full-title></periodical><alt-periodical><full-title>Lancet (London, England)</full-title></alt-periodical><pages>1317-9</pages><volume>340</volume><number>8831</number><edition>1992/11/28</edition><keywords><keyword>Centrifugation, Density Gradient/methods/standards</keyword><keyword>Disinfection/methods/*standards</keyword><keyword>Feasibility Studies</keyword><keyword>Female</keyword><keyword>Follow-Up Studies</keyword><keyword>HIV Infections/*prevention & control/transmission</keyword><keyword>*hiv-1</keyword><keyword>Humans</keyword><keyword>Insemination, Artificial, Homologous/methods/*standards</keyword><keyword>Italy</keyword><keyword>Male</keyword><keyword>Pregnancy</keyword><keyword>*Pregnancy Outcome</keyword></keywords><dates><year>1992</year><pub-dates><date>Nov 28</date></pub-dates></dates><isbn>0140-6736 (Print)
0140-6736</isbn><accession-num>1360037</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>43This technique however is highly specialised and only available in highly specialised laboratories. It also has high cost implication and should be reserved for high resource settings.Infertility treatment for people living with HIVPeople living with HIV should also have access to full range of investigations. Antiretroviral (ARV) therapy must be optimised before attempting to conceive.Consistent use of ARVs with good adherence to treatment.Viral load must be undetectable< 200 copies/ml.Monitoring of viral loads every 3-6 months to ensure sustained viral suppression.Infertility treatment must be individualised.Consider condomless sexual intercourse in those with no infertility diagnosis. Condomless sex should only be undertaken once adherence is confirmed and HIV-positive client is virally suppressed.All clients should be screened for active STI and both partners treated, should there be evidence of STI in either or both partners.Offer assisted reproductive technology when indicated.These guidelines are aligned with recommendations of the Southern African HIV Clinicians Society (SAHIVCS) guidelines and PMTCT guidelines.Table SEQ Table \* ARABIC 8. Reproductive options for people living with HIVHIV+ woman HIV- manHIV+ man HIV- womanBoth HIV+Antiretroviral therapyUndetectable viral load <200 copies/mlFertility not an issue Condomless sexTimed condomless sex*/Self-inseminationConsider PrEP if female not on ARVs > 6 months and viral load >200 copies/mlInfertility an issue IUI/IVF/ICSIAdoptionAntiretroviral therapyUndetectable viral load <200 copies/mlFertility not an issue Condomless sexTimed condomless sex*Consider PrEP if female not on ARVs > 6 months and viral load >200 copies/mlInfertility an issueSperm washingIUI/IVF/ICSIDonor spermAdoptionAntiretroviral therapyUndetectable viral load <200 copies/mlFertility not an issue Condomless sexTimed condomless sex*Infertility an issueSperm washingIUI/IVF/ICSIDonor spermAdoption* Timed condomless sex is recommended if:Positive partner(s) not confirmed VL <200 copies/mlViral load monitoring availableClient preferenceNo STI’sFertility treatment for single person or LGBTQI-86179652000Single persons and the LBGTI community should be free to exercise their sexual and reproductive rights and desire to build a family. Service provision should be non-judgemental, supportive, and understanding. When seeking fertility treatment, they should have access to the full range of investigations and treatment. Treatment options should be discussed with the healthcare provider and should be individualised. REF _Ref4654162 \h Figure 10 depicts the standard of care to be provided. Figure SEQ Figure \* ARABIC 10. Standard of care for single and LGBTQI personsFertility treatment for the medically complicated personsPersons with medical conditions seeking ART should be managed by a multidisciplinary team comprising of a reproductive medicine specialist, physician, feto-maternal specialists, and specialists in the medical condition. Important issues to be taken into consideration are; the effects of pregnancy on the disease, the effects of the disease on the pregnancy, effects of the disease on reproduction, and the effects of ART on the disease. All persons with medical diseases should be optimised before initiating ART. The following are a list of disorders that require assessment and optimisation before ART:HypertensionCardiac DiseasesRenal Failure and renal transplantEndocrinopathies; diabetes Mellitus, hyperprolactinaemia and thyroid diseasesEpilepsyAutoimmune disordersThrombo-embolic disordersObesityCancerKey Areas:Sexual and reproductive health and rights is a priorityAll persons regardless of their sexual orientation have a right to build a familyThere must be access to individualised treatmentPreconception care is important to ensure optimisation for pregnancy and good pregnancy outcomesFertility services must be provided in a supportive, non-judgemental, and friendly environmentKey Areas:Sexual and reproductive health and rights is a priorityAll persons regardless of their sexual orientation have a right to build a familyThere must be access to individualised treatmentPreconception care is important to ensure optimisation for pregnancy and good pregnancy outcomesFertility services must be provided in a supportive, non-judgemental, and friendly environmentAssisted reproductive technology (ART)ART procedure is any procedure where eggs are surgically removed from the woman’s ovaries and combined with sperm in a laboratory setting and returned to a woman’s uterus. 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ADDIN EN.CITE.DATA 1 Artificial insemination though not included in the definition of ART, forms part of the armament of treatment for infertility. Ovulation induction is required for ART. This is a process whereby exogenous medication is used to assist with ovulation. With IVF and ICSI, controlled ovarian hyperstimulation is used, which is stimulating multiple follicles to develop for the purposes of surgical removal for ART. Indications and complications of the different ART procedures are shown in REF _Ref4654583 \h Table 9 below.Table SEQ Table \* ARABIC 9. ART proceduresIndicationsComplicationsIUIUnexplained InfertilityMild male factorMild endometriosisCervical factorsSexual disordersSame sex/single personsMultiple pregnancyOHSSIVFTubal factorFailed IUISevere endometriosisDiminished ovarian reserveOHSSMultiple pregnancySide effects of drugsEgg retrieval procedure complicationsEctopic pregnancyObstetric complicationsCost of treatmentICSIMale factorFertilisation failure with IVFFertilisation with epidydimal/testicular sampleFertilisation with cryopreserved spermFertilisation with immotile spermOHSSMultiple pregnancySide effects of drugsEgg retrieval procedure complicationsEctopic pregnancyObstetric complicationsCost of treatmentSurrogacyAbsence of a uterusHysterectomyCongenital abnormalitySevere uterine abnormalitiesAsherman’s syndromeEndometrial damageMedical conditions where pregnancy is contraindicatedChronic reproductive lossSame sex male couples/single menOHSSSide effects of drugsDepressionReproductive laboratoryIntroductionLaboratory procedures form a fundamental part of assisted reproduction technologies (ART) and selection thereof is crucial. To determine the appropriate procedure to follow, both the male and female components involved should be evaluated. Three major factors to consider are whether the female has patent fallopian tubes, if there is male factor subfertility, and history of previous ART treatment cycles.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZW5zZG9ycDwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+
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ADDIN EN.CITE.DATA 14, 45, 46, 48-52ART laboratory procedures include, but are not limited to:Semen processing (combined with decontamination if necessary)Surgical sperm retrieval for obstructive and non-obstructive azoospermiaIntrauterine insemination (IUI)In vitro fertilization (IVF), with or without the use of intracytoplasmic sperm injection (ICSI), through the use of the patient’s own or donor gametesEmbryo transfer to the patient or their agreed upon surrogateCryopreservation and storage of gametes and embryosOther e.g. embryo biopsy for pre-implantation genetic screening, time-lapse embryo culture, and sperm functional testingOperational requirementsReproductive laboratory facilities, diagnostic workout of patients, gamete preparation, and embryo culture are an integral part of the ART Unit. The laboratory is an essential part of assisted reproduction and before performing any procedures, an embryo-safe environment must be guaranteed. The minimum staff and equipment requirements for essential procedures can be seen in REF _Ref4655274 \h \* MERGEFORMAT Table 10. To safeguard this embryo-safe environment, access control to the laboratory must be maintained.Table SEQ Table \* ARABIC 10. Minimum staff and equipment requirements for ART proceduresLevel of careProceduresStaffEquipmentDiagnosticSemen analysisAndrologist/Embryologist ORClass II Biological Safety CabinetAppropriate sized pipettesAppropriate counting chamberUpright microscope with:Phase contrast20x, 40x, 100x magnificationTrained laboratory technologist (in conjunction with a calibrated Computer Assisted Sperm Analyzer (CASA) and satellite laboratory to confirm results if no Andrologist/Embryologist is available)Same as above, with camera and CASA system attached to microscopeInternet access to send CASA videoTherapeutic - BasicSemen processing (IUI)Andrologist/Embryologist Same as for Semen analysisCentrifuge with swing-out rotorsTherapeutic - Advanced- Embryo culture- ICSI- Embryo transfer- CryopreservationLab director (Embryologist) with:PhD ORMaster's degree and five years of clinical experience ORTen years of clinical experience At least one additional EmbryologistIf more than 150 ART cycles performed per year, an additional Embryologist for every 150 ART cyclesSame as for Semen processingLaboratory with HEPA filtered air supplyMedical fridgeEmbryo culture incubator with appropriate gas supplyLaminar flow cabinetInverted microscope with:Modulation contrast5/10x and 20/40x magnificationMicromanipulators for ICSILiquid nitrogen (LN2) dewars and reliable LN2 supplyUninterrupted power supply for Embryo culture incubators, fridge and microscopesLaboratory personnelEmbryologists are specialist laboratory staff who take care and maintain human gametes and embryos in an optimal condition according to good laboratory practices. Embryologists in South Africa fall into two groups: (i) Medical biological scientists (Medical & Dental & Medical Sciences HPCSA board) and (ii) Clinical technologists (Radiography & Clinical Technology HPCSA board). Sufficient number of trained embryologists must be available for appropriate laboratory operations ( REF _Ref4655274 \h \* MERGEFORMAT Table 10).PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb250YWc8L0F1dGhvcj48WWVhcj4yMDE3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 53-55EnvironmentThe location, structure, building materials, fittings and furniture inside the laboratory should be chosen to limit volatile organic contaminants. ADDIN EN.CITE <EndNote><Cite><Author>Cobo A</Author><RecNum>313</RecNum><DisplayText><style face="superscript">56</style></DisplayText><record><rec-number>313</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553740823">313</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Cobo A, </author><author>Coello A,</author></authors></contributors><titles><title>Chapter 15. Vitrification – Oocytes, 2PN, Embryos, Blastocysts</title><secondary-title>In: Rizk, B., Montag, S. eds. Standard Operational Procedures in Reproductive Medicine: Laboratory and Clinical Practice</secondary-title></titles><pages>p 36-37</pages><dates></dates><pub-location>Oxfordshire, UK</pub-location><publisher>CRC Press</publisher><urls></urls></record></Cite></EndNote>56 A “burning-in” period of six weeks is advised for any new equipment prior to the initiation of ART cycles. ADDIN EN.CITE <EndNote><Cite><Author>Cobo A</Author><RecNum>313</RecNum><DisplayText><style face="superscript">56</style></DisplayText><record><rec-number>313</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553740823">313</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Cobo A, </author><author>Coello A,</author></authors></contributors><titles><title>Chapter 15. Vitrification – Oocytes, 2PN, Embryos, Blastocysts</title><secondary-title>In: Rizk, B., Montag, S. eds. Standard Operational Procedures in Reproductive Medicine: Laboratory and Clinical Practice</secondary-title></titles><pages>p 36-37</pages><dates></dates><pub-location>Oxfordshire, UK</pub-location><publisher>CRC Press</publisher><urls></urls></record></Cite></EndNote>56Ambient airAir quality depends on the number and size of particles and microorganisms/VOCs found in the air and can be maintained by the use PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IdXlzZXI8L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 55, 57-59 of (i) high efficiency particulate air (HEPA) filtration in conjunction with (ii) activated carbon and potassium permanganate filters and (iii) positive air pressure (10-15 Pascal difference) to displace air from the most to the least critical areas in the ART facility. ADDIN EN.CITE <EndNote><Cite><Author>Montag</Author><Year>2017</Year><RecNum>310</RecNum><DisplayText><style face="superscript">53, 58</style></DisplayText><record><rec-number>310</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553740489">310</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Montag, M</author></authors></contributors><titles><title>Chapter 29. Microscopy</title><secondary-title>Rizk, B., Montag, S. eds. Standard Operational Procedures in Reproductive Medicine: Laboratory and Clinical Practice</secondary-title></titles><pages>p 72-73</pages><dates><year>2017</year></dates><pub-location>Oxfordshire, UK</pub-location><publisher>CRC Press</publisher><urls></urls></record></Cite><Cite><Author>Guns</Author><Year>2012</Year><RecNum>315</RecNum><record><rec-number>315</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553741070">315</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Guns, J., Janssens, R., Vercammen, M. </author></authors></contributors><titles><title>Air quality management</title><secondary-title>In: Nagy, Z.P., Varghese, A.C, Agarwal, A. eds. Practice manual of in vitro fertilization</secondary-title></titles><pages>p 17-25</pages><dates><year>2012</year></dates><pub-location>New York, USA</pub-location><publisher>Springer</publisher><urls></urls></record></Cite></EndNote>53, 58 Yearly particulate testing and microbial culture can be done to monitor and validate air quality. ADDIN EN.CITE <EndNote><Cite><Author>Elder</Author><Year>2015</Year><RecNum>317</RecNum><DisplayText><style face="superscript">60</style></DisplayText><record><rec-number>317</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553741301">317</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Elder, K., Van den Bergh M., Woodward, B.</author></authors></contributors><titles><title>Troubleshooting and problem-solving in the IVF laboratory</title></titles><dates><year>2015</year></dates><pub-location>Cambridge, UK</pub-location><publisher>Cambridge University Press</publisher><urls></urls></record></Cite></EndNote>60Light exposureLight source and filters can be selected to reduce exposure of gametes and embryos to harmful wavelengths, while direct sunlight in the embryology lab should be avoided.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZW5zZG9ycDwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+
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ADDIN EN.CITE.DATA 53, 54SpermatologySemen analysisThe results from a basic semen analysis (with confirmation of abnormal results with a second semen analysis), performed according to the WHO manual for the examination and processing of human semen ADDIN EN.CITE <EndNote><Cite><Author>World Health Organization</Author><RecNum>269</RecNum><DisplayText><style face="superscript">14</style></DisplayText><record><rec-number>269</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553673474">269</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>World Health Organization,</author></authors></contributors><titles><title>WHO laboratory manual for the examination and processing of human semen, Fifth edition</title></titles><dates></dates><urls></urls></record></Cite></EndNote>14 and as described in “Section 9: Male factor infertility”, can be used to determine mild or severe mild factor infertility.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Xb3JsZCBIZWFsdGggT3JnYW5pemF0aW9uPC9BdXRob3I+
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ADDIN EN.CITE.DATA 45-47Sperm processingFor therapeutic procedures, spermatozoa must be removed from the complete semen sample, containing microorganisms, senescent and immature sperm, non-sperm cells, and cell detritus. This can be performed by the following techniques (see addendum for detailed explanation):Simple washingDirect swim-upDensity gradient centrifugation (in combination with decontamination if needed)Sperm processing in conjunction with decontamination is advised when seminal pathogens needs to be removed prior to ART treatment.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FbmdsZXJ0PC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48
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ADDIN EN.CITE.DATA 62 This could include males with blood borne viruses (BBV) (e.g. HIV, Hepatitis C etc.) with detectable blood or seminal viral loads.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FbmdsZXJ0PC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48
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ADDIN EN.CITE.DATA 52-54 Common identifiers used in conjunction are patient’s name and birth date, a unique numerical identifier, and date of the procedure.Gamete removal and combinationOocyte removal should be performed in conjunction between the clinician and embryologist. Insemination of oocytes should occur between 38 and 40 hours after human chorionic gonadotropin (HCG) trigger. ADDIN EN.CITE <EndNote><Cite><Author>Montag</Author><Year>2017</Year><RecNum>310</RecNum><DisplayText><style face="superscript">52, 53</style></DisplayText><record><rec-number>310</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553740489">310</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Montag, M</author></authors></contributors><titles><title>Chapter 29. Microscopy</title><secondary-title>Rizk, B., Montag, S. eds. Standard Operational Procedures in Reproductive Medicine: Laboratory and Clinical Practice</secondary-title></titles><pages>p 72-73</pages><dates><year>2017</year></dates><pub-location>Oxfordshire, UK</pub-location><publisher>CRC Press</publisher><urls></urls></record></Cite><Cite><Year>2018</Year><RecNum>309</RecNum><record><rec-number>309</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553740363">309</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><auth-address>American Society for Reproductive Medicine, Birmingham, Alabama.</auth-address><titles><title>Management of nonobstructive azoospermia: a committee opinion</title><secondary-title>Fertil Steril</secondary-title><alt-title>Fertility and sterility</alt-title></titles><periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></periodical><alt-periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></alt-periodical><pages>1239-1245</pages><volume>110</volume><number>7</number><edition>2018/12/07</edition><dates><year>2018</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0015-0282</isbn><accession-num>30503112</accession-num><urls></urls><electronic-resource-num>10.1016/j.fertnstert.2018.09.012</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>52, 53 The selection of insemination procedure (IVF vs. ICSI) should be according to sperm profile, as well as patient history and previous ART cycles. ADDIN EN.CITE <EndNote><Cite><Author>Montag</Author><Year>2017</Year><RecNum>310</RecNum><DisplayText><style face="superscript">52, 53</style></DisplayText><record><rec-number>310</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553740489">310</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Montag, M</author></authors></contributors><titles><title>Chapter 29. Microscopy</title><secondary-title>Rizk, B., Montag, S. eds. Standard Operational Procedures in Reproductive Medicine: Laboratory and Clinical Practice</secondary-title></titles><pages>p 72-73</pages><dates><year>2017</year></dates><pub-location>Oxfordshire, UK</pub-location><publisher>CRC Press</publisher><urls></urls></record></Cite><Cite><Year>2018</Year><RecNum>309</RecNum><record><rec-number>309</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553740363">309</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><auth-address>American Society for Reproductive Medicine, Birmingham, Alabama.</auth-address><titles><title>Management of nonobstructive azoospermia: a committee opinion</title><secondary-title>Fertil Steril</secondary-title><alt-title>Fertility and sterility</alt-title></titles><periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></periodical><alt-periodical><full-title>Fertil Steril</full-title><abbr-1>Fertility and sterility</abbr-1></alt-periodical><pages>1239-1245</pages><volume>110</volume><number>7</number><edition>2018/12/07</edition><dates><year>2018</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0015-0282</isbn><accession-num>30503112</accession-num><urls></urls><electronic-resource-num>10.1016/j.fertnstert.2018.09.012</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>52, 53 Standard operational procedural details on performing an ICSI and IVF insemination are described in detail by Freour (2017) and Montag (2017).Embryo cultureEmbryo culture conditions are influenced by availability of equipment as well as personal preference (see addendum). 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ADDIN EN.CITE.DATA 49, 53Figure SEQ Figure \* ARABIC 12. Overview of embryo evaluation timepointsEmbryo Transfer Each patient is unique and factors influencing the day of embryo transfer (ET) and number of embryos to be transferred should be considered before any selections are made. Day 5 of culture is preferred for embryo transfer, but if three or less oocytes fertilized normally or embryo culture cannot be supported for five days, ET can be performed on Day 3 of culture.PEVuZE5vdGU+PENpdGU+PFllYXI+MjAxNzwvWWVhcj48UmVjTnVtPjMwNjwvUmVjTnVtPjxEaXNw
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ADDIN EN.CITE.DATA 49-51, 53Embryo evaluation and recommendation of number for transfer should be discussed with the patients. No more than 2 embryos should be transferred. For patients younger than 35 years of age and good embryo quality, a single blastocyst transfer on day 5 of culture is advised.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb250YWc8L0F1dGhvcj48WWVhcj4yMDE3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 50, 52, 53CryopreservationCryopreservation is used to preserve and store excess or back-up gametes and embryos. Selection of cryopreservation method will determine the equipment needed. Internationally, vitrification of oocytes and embryos is preferred.Strict criteria for selection of cryopreservable material is essentialPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb250YWc8L0F1dGhvcj48WWVhcj4yMDE3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 49, 52, 53Oocyte vitrification is advised to take place within two hours of oocyte collection and when warmed the oocytes should be ICSI’s within two hours of warming ADDIN EN.CITE <EndNote><Cite><Author>National Institute for Health and Care Excellence</Author><Year>2013</Year><RecNum>304</RecNum><DisplayText><style face="superscript">47</style></DisplayText><record><rec-number>304</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553739954">304</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>National Institute for Health and Care Excellence,</author></authors></contributors><titles><title>Fertility: assessment and treatment for people with fertility problems</title></titles><dates><year>2013</year></dates><urls></urls></record></Cite></EndNote>47Closed cryopreservation systems and separate storage dewars are advised to be used when working with gametes or embryos from BBV positive patientsPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FbmdsZXJ0PC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48
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ADDIN EN.CITE.DATA 62, 63Record keeping of cryopreserved material as well as upkeep of the liquid nitrogen canisters this material is stored in should be kept safe, with a scheduled back-up systemClear indicator as to where specific samples are stored with easily recognisable identifiers must be usedStandard operating procedures Standard operative procedures (SOPs) as part of the documentation system of the ART Unit should detail the necessary steps for the operation of equipment, execution of procedures, materials needed, and steps to follow.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb250YWc8L0F1dGhvcj48WWVhcj4yMDE3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 53, 54, 64 The use of flow diagrams for ease of understanding procedural steps is recommended. This system forms the backbone of an ART Unit, to ensure:Adherence and consequently consistency through the standardization of a procedureOptimizing procedural and environmental conditionsSafety measures (e.g. double witnessing of samples; difficult ART procedure)How to deal with emergencies (e.g. equipment malfunctioning/human errors/power failures etc.)These policies and laboratory guidelines should include:Responsibilities and qualifications of laboratory staffRisk reduction measures (with specific reference to infectious agents) Aseptic standards of/protective measures in the reproductive laboratoryThis forms part of internationally accepted good laboratory practices and is essential to operate and provide the best clinical outcome for patients.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb250YWc8L0F1dGhvcj48WWVhcj4yMDE3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 53, 54, 64Key Areas:Male and female diagnostic workup to identify correct procedure to followThere must be patient and sample identification and traceabilityAn embryo-safe culture environment is crucialDecisions on appropriate identification of day of transfer and number of embryos to transfer (maximum 2) must be made by both clinician and embryologistFacilities must be available for cryopreservation of excess embryos and/or gametesKey Areas:Male and female diagnostic workup to identify correct procedure to followThere must be patient and sample identification and traceabilityAn embryo-safe culture environment is crucialDecisions on appropriate identification of day of transfer and number of embryos to transfer (maximum 2) must be made by both clinician and embryologistFacilities must be available for cryopreservation of excess embryos and/or gametesService delivery platformTable SEQ Table \* ARABIC 11. Minimum staffing and equipment requirements at specialised fertility unitsMinimum staffing requirementsMinimum equipment requirementMinimum service delivery packageSpecialised Infertility ClinicReproductive Medicine Specialist (clinician with appropriate qualifications)Specialised fertility nursesAnaesthetistFacility for tubal testing e.g. HSGNHLS laboratory servicesPsychologistAdministrative staffAspiration roomEmbryo transfer roomUltrasound with transvaginal probeTheatre equipmentResuscitation trolleyConsumablesGynae packFiling cabinetsCounsellingInvestigationsARTSurgery to improve fertilityReproductive Biology ProceduresLab director (Embryologist) with any of the PhD orMaster's DEGREE and five years of clinical experience or Ten years of clinical experience At least one additional EmbryologistIf more than 150 ART cycles performed per year, an additional embryologist for every 150 ART cyclesAndrologistTrained laboratory technologistAdministrative staffClass II Biological Safety CabinetAppropriate sized pipettesAppropriate counting chamberUpright microscope with: Phase contrast20x, 40x, 100x magnificationCentrifuge with swing-out rotorsLaboratory with HEPA filtered air supplyMedical fridgeEmbryo culture incubator with appropriate gas supply Laminar flow cabinet Inverted microscope with:Modulation contrast5/10x and 20/40x magnificationMicromanipulators for ICSILiquid nitrogen (LN2) dewars & reliable LN2 supplyUninterrupted power supply for embryo culture incubators, fridge and microscopesSemen analysisDiagnosticTherapeuticAdvanced therapeutic ARTTable SEQ Table \* ARABIC 12. Minimum staffing and equipment requirements at level 2/3 infertility unitsMinimum staffingrequirementsMinimum equipmentrequirementMinimum service delivery packageLevel 2/3 Infertility ClinicClinician with appropriate qualificationsRegistered nursesFacility for tubal testing e.g. HSGNHLS laboratory servicesPsychologistAdministrative staffProcedure roomUltrasound with transvaginal probeConsumablesGynae packFiling cabinetsCounsellingInvestigationsIUIMinor surgery to improve fertilityReproductive Biology proceduresTrained laboratory technologist with a calibrated Computer Assisted Sperm Analyzer (CASA) Satellite laboratory to confirm results (if no Andrologist / Embryologist is available)Class II Biological Safety CabinetAppropriate sized pipettesAppropriate counting chamberUpright microscope with: Phase contrast20x, 40x, 100x magnificationCASA system attached to microscopeInternet access to send CASA video Centrifuge with swing-out rotorsSemen AnalysisDiagnosticSemen processing for IUIAddendumTable SEQ Table \* ARABIC 13. Example of equipment used in ART laboratory, with proposed maintenance and quality control scheduleTable SEQ Table \* ARABIC 14. Sperm preparation techniqueSimple washingRemoval of sperm from the seminal plasma through several washes and centrifugation cycles. Using normal semen samples without any possible pathogens or excess cellular debris for IUI. This can be used in combination with a swim-up step.208734154940Direct swim-upLayering of liquefied semen under culture medium, or medium over the semen, resulting in a lower sperm yield, but a highly motile sperm fraction. Increasing the surface area of the semen-medium interface and using multiple round bottom tubes or 4-well dishes can improve sperm yield. ADDIN EN.CITE <EndNote><Cite><Author>Henkel</Author><Year>2003</Year><RecNum>322</RecNum><DisplayText><style face="superscript">65</style></DisplayText><record><rec-number>322</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553747671">322</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Henkel, Ralf R.</author><author>Schill, Wolf-Bernhard</author></authors></contributors><titles><title>Sperm preparation for ART</title><secondary-title>Reproductive Biology and Endocrinology</secondary-title></titles><periodical><full-title>Reproductive Biology and Endocrinology</full-title></periodical><pages>108</pages><volume>1</volume><number>1</number><dates><year>2003</year><pub-dates><date>2003/11/14</date></pub-dates></dates><isbn>1477-7827</isbn><urls><related-urls><url> gradientDiscontinuous density gradient centrifugation offers the best selection of consistent good quality sperm for IUI, IVF and ICSI procedures. The procedure utilises colloidal silica coated with silane and separates cells based upon their density or specific gravity. Mature motile sperm actively migrate into the bottom density gradient layer. ADDIN EN.CITE <EndNote><Cite><Author>Henkel</Author><Year>2003</Year><RecNum>322</RecNum><DisplayText><style face="superscript">65</style></DisplayText><record><rec-number>322</rec-number><foreign-keys><key app="EN" db-id="eare2taxlax2sqezt0kv0afm2vr2vt95dwsz" timestamp="1553747671">322</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Henkel, Ralf R.</author><author>Schill, Wolf-Bernhard</author></authors></contributors><titles><title>Sperm preparation for ART</title><secondary-title>Reproductive Biology and Endocrinology</secondary-title></titles><periodical><full-title>Reproductive Biology and Endocrinology</full-title></periodical><pages>108</pages><volume>1</volume><number>1</number><dates><year>2003</year><pub-dates><date>2003/11/14</date></pub-dates></dates><isbn>1477-7827</isbn><urls><related-urls><url> gradient centrifugation in combination with sperm swim-upDiscard aspirated supernatants (gradients and cellular debris) from the conical tube, with sperm pellet containing the motile sperm fraction re-suspended in media. 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ADDIN EN.CITE.DATA 663590661928700Table SEQ Table \* ARABIC 15. Summary of critical elements during embryo cultureCulture media type(Hardarson et al., 2015)One-stepAll necessary components present in the media in excess, the embryo uses specific components as neededContinues culture, especially beneficial when used with time-lapse incubationSequentialMedia composition change according to developmental stageMedia change necessary on day three of cultureOil overlay(Sifer et al., 2009)WithTemperature and osmolarity bufferPhysical barrierTakes longer for media to gas, but also to out-gasWithoutMedia in direct contact with ambient airIncubation system must be humidifiedEmbryo evaluation (Basille et al., 2015; Meseguer et al., 2012; Zhang et al., 2010;)Time-lapseTiming of evaluations are flexibleEmbryos remain in culture during evaluationMore information available per embryoBetter visualisation of morphokinetic eventsAutomated algorithms to assist in embryo selectionExpensiveStaticSingle time-point evaluation of embryos - morphokinetic events can easily be missedEmbryo has to be removed from incubation during evaluationLess expensiveDuration of culture(Chang et al., 2009; Kovacic et al., 2010)Three daysIncubation with carbon dioxide in airCleavage stage transfer & cryopreservationFive daysTri-gas incubationBlastocyst stage transfer & cryopreservationAcknowledgementsWe acknowledge the following individuals who contributed in the drafting of this document and are part of the guideline development group:Dr Zozo Nene - Reproductive Medicine Sub-Specialist (University of Pretoria & Steve Biko Academic Hospital)Dr Jack Biko - Reproductive Medicine Sub-Specialist (University of Pretoria & Steve Biko Academic Hospital)Dr Marienus Trouw - Reproductive Medicine Sub-Specialist (University of Pretoria & Steve Biko Academic Hospital)Dr Malika Patel - Reproductive Medicine Sub-Specialist (University of Cape Town & Groote Schuur Hospital)Prof Carin Huyser - Embryologist (University of Pretoria & Steve Biko Academic Hospital)Mr Gerhard Boshoff - Embryologist (University of Pretoria & Steve Biko Academic Hospital)In addition, we would like to acknowledge the following individuals, societies, and institutions: SASREG for their input; Mr M Bakker for the visual representations in the ART Laboratory procedures section; Mrs. L Boyd for editing and referencing; Ms Natasha Davies for input on the chapter on safe conception for people living with HIV. 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