Recommendations from the WHO guideline for the prevention, diagnosis, and treatment of infertility

STUDY QUESTION: What is the recommended prevention, diagnosis, and treatment of infertility among individuals and couples? SUMMARY ANSWER: The World Health Organization (WHO) made 40 recommendations and six good practice statements for the prevention, diagnosis, and treatment of infertility. WHAT IS KNOWN ALREADY: The field of sexual and reproductive health care, including family planning has progressed in the last several decades. Significant progress has also been made in the field of medically assisted reproduction. Globally, one in six people experience infertility in their lifetime. However, many countries do not include the prevention, diagnosis, and treatment of infertility in health policies, financing, and services, and many do not have national clinical guidelines for the prevention, diagnosis, and treatment of infertility. STUDY DESIGN, SIZE, DURATION: The guideline was developed according to the WHO handbook for guideline development. A Guideline Development Group (GDG) was assembled and included a multidisciplinary and regionally diverse set of clinicians, policymakers, researchers, implementers, and representatives of patient groups (n=30). The GDG prioritized key recommendation questions to address in the guideline. PARTICIPANTS/MATERIALS, SETTING, METHODS: New systematic reviews were conducted, or existing reviews updated, to inform the recommendations. The GRADE approach was used to assess the certainty of the evidence and to guide the formulation of recommendations. The GDG interpreted evidence and made judgments about the balance between benefits and harms (including patients' values) as well as costs, feasibility, acceptability, and equity. The recommendations were drafted, reviewed by an External Review Group (ERG) comprising 30 members, and approved by the WHO. MAIN RESULTS AND THE ROLE OF CHANCE: The guideline makes good practice statements related to the general management of infertility (n = 6) including (i) selection of tests, (ii) listening to individuals and couples with infertility, (iii) choosing treatment decisions, (iv) clinical follow-up, and (v) documenting outcomes of treatment. In relation to prevention, it provides recommendations related to the provision of information about fertility and infertility (n = 1) and reduction of infertility risk from sexually transmitted infections (STIs; n = 1), lifestyle factors (n = 1), and tobacco use (n = 1). In terms of diagnosis, recommendations for diagnosing infertility caused by ovulatory dysfunction (n = 3), tubal disease (n = 1), or uterine cavity abnormalities (n = 5) among females are provided. For males, the guideline provides recommendations regarding when a semen test should be repeated (n = 2). Also included is a recommendation for diagnosing unexplained infertility (n = 1). Regarding treatment, the guideline provides recommendations related to the treatment of polycystic ovary syndrome (n = 6), tubal disease (n = 5), uterine septae (n = 1), varicocele (n = 4), and unexplained infertility (n = 6). Based on available evidence, the GDG did not make a recommendation for or against the use of antioxidant supplements in males. Most recommendations were conditional because relevant evidence was either absent, or of low or very low certainty. Critical research gaps were identified. LIMITATIONS, REASONS FOR CAUTION: The recommendations do not cover all aspects of infertility and fertility care, but subsequent editions of the guideline will expand the scope of recommendations. WIDER IMPLICATIONS OF THE FINDINGS: By centring equity, science, and the imperative to provide fertility care as part of universal health coverage, the guideline aims to support countries in delivering high-quality, equitable, and effective healthcare for all. Although the guideline is primarily intended for use by health care professionals, it is an important source for policymakers to inform national guidelines and to inform the work of professional patient support, including advocacy organizations, funding and philanthropic agencies, civil society, professional societies, and other nongovernmental organizations that provide social, financial, and technical support to reproductive health programmes. STUDY FUNDING/COMPETING INTEREST(S): This work received funding from the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO). Full details of declared interests of all named authors are shown in Supplementary Table S1, those for members of the GDG who are not named authors are shown in Supplementary Table S2 and those for members of the ERG are shown in Supplementary Table S3. TRIAL REGISTRATION NUMBER: N/A. DISCLAIMER: This manuscript reports a summary of recommendations from a WHO guideline. All reasonable precautions have been taken by WHO to verify the information contained in the guideline publication. However, the published material is being distributed without warranty of any kind, either expressed or implied.

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