Enhancing cultural sensitivity in the implementation of the Fertility Quality of Life Tool in Sudan: a science diplomacy perspective.

Background: Infertility is a global health challenge impacting quality of life, particularly in low and middle-income countries such as Sudan. The Fertility Quality of Life (FertiQoL) tool, a standardized questionnaire, is pivotal in assessing fertility-related quality of life. However, existing research on its utility has primarily been conducted in Global North and High-Income Countries, highlighting the need to shift away from neocolonialism to promote truly inclusive research and effective healthcare practices. Science diplomacy, through the adaptation and culturally sensitive implementation of research tools, can serve as a catalyst for addressing health disparities on a global scale. This study aims to assess methodological and cultural considerations that impact the implementation of the FertiQoL tool in Sudan, framed within the context of science diplomacy and neocolonialism. By investigating the challenges and opportunities of utilizing this tool in a non-Western cultural setting, we seek to contribute to the broader discussion on decolonizing global health research. Methods: Utilizing an explanatory sequential design involving surveys and interviews, we conducted a study in a Sudanese fertility clinic from November 2017 to May 2018. A total of 102 participants were recruited using convenience sampling, providing socio-demographic, medical, and reproductive history data. The Arabic version of FertiQoL was administered, with 20 participants interviewed and 82 surveyed (40 self-administered and 42 provider-administered). We applied descriptive statistics, one-way ANOVA, thematic analysis, and triangulation to explore methodological and cultural nuances. Results: Most participants were educated women who lived in urban areas. While the ANOVA results revealed no statistically significant differences in FertiQoL scores based on the mode of administration [core score (F(2,99) = 1.58, p = 0.21, η 2 = 0.03) and domain scores: emotional (F(2,99) = 1.85, p = 0.16, η 2 = 0.04); mind/body (F(2,99) = 1.95, p = 0.15, η 2 = 0.04); relational (F(2,99) = 0.18, p = 0.83, η 2 = 0.04); and social (F(2,99) = 1.67, p = 0.19, η 2 = 0.03)], qualitative insights unveiled vital cultural considerations. Interpretation challenges related to concepts like hope and jealousy emerged during interviews. Notably, the social domain of FertiQoL was found to inadequately capture the social pressures experienced by infertile individuals in Sudan, underscoring the importance of region-specific research. Despite these challenges, participants perceived FertiQoL as a comprehensive and valuable tool with broader utility beyond assessing fertility-related quality of life. Conclusion: Our findings emphasize the significance of incorporating cultural sensitivity into the interpretation of FertiQoL scores when implementing it globally. This approach aligns with the principles of science diplomacy and challenges neocolonial structures by acknowledging the unique lived experiences of local populations. By fostering cross-cultural understanding and inclusivity in research, we can enhance the implementation of FertiQoL and pave the way for novel interventions, increased funding, and policy developments in the Global South, ultimately promoting equitable global health.

Business case for psychosocial interventions in clinics: potential for decrease in treatment discontinuation and costs.

RESEARCH QUESTION: From a value-based healthcare (VBHC) perspective, does an assessment of clinical outcomes and intervention costs indicate that providing cognitive behavioural therapy (CBT) or mindfulness to women seeking fertility treatment add value compared with no such intervention? DESIGN: Proof-of-concept business case based on a VBHC perspective that considers clinical outcomes and costs. Potential effects on psychological and fertility outcomes were based on existing research. Cost outcomes were estimated with a costing model for the Dutch fertility treatment setting. RESULTS: Thirty-two studies were identified; 13 were included. Women who received CBT had 12% lower anxiety, 40% lower depression and 6% higher fertility quality of life; difference in clinical pregnancy rates was six percentage points (CBT [30.2%]; control [24.2%]); difference in fertility discontinuation rates was 10 percentage points (CBT [5.5%]; control [15.2%]). Women who received training in mindfulness had 8% lower anxiety, 45% lower depression and 21% higher fertility quality of life; difference in mean clinical pregnancy rate was 19 percentage points (mindfulness [44.8%]; control [26.0%]). Potential total cost savings was about €1.2 million per year if CBT was provided and €11 million if mindfulness was provided. Corresponding return on investment for CBT was 30.7%, and for mindfulness 288%. Potential cost benefits are influenced by the assumed clinical pregnancy rates; such data related to mindfulness were limited to one study. CONCLUSIONS: The provision of CBT or mindfulness to women seeking fertility treatment could add value. Higher quality primary studies are needed on the effect of mindfulness on clinical pregnancy rates.

Challenges experienced by those with polycystic ovary syndrome in healthcare interactions: a qualitative evidence synthesis.

Studies report interaction difficulties between patients with polycystic ovary syndrome (PCOS) and healthcare professionals (HCP). This systematic review and qualitative evidence synthesis aimed to collate and synthesize the existing peer-reviewed literature investigating challenges for people with PCOS when interacting with HCP. Medline, PsycInfo, EMBASE, All EBM and CINAHL were searched from 1990 to September 2022. Study risk of bias (RoB) was performed and all textual data relevant to challenging interactions between patients with PCOS and HCP were extracted and analysed using thematic synthesis. Of the 6353 studies identified, 28 were included. Two were appraised as high, four as moderate and 22 as low RoB. Four analytic themes were derived illustrating that interactions were challenging when: (i) medical information (PCOS, its management) was not shared in the best way; (ii) information provision and deliberation opportunities were insufficient to achieve outcomes that mattered to patients; (iii) interactions prompted but did not support patient activation; and (iv) health system-level barriers (e.g. policies and guidelines) were present or made worse by HCP behaviour. Future research should examine methods for the implementation and evaluation of established frameworks for sharing medical information and supporting patient agency in the context of PCOS care.

Evaluating source credibility effects in health labelling using vending machines in a hospital setting.

OBJECTIVES: Providing advice to consumers in the form of labelling may mitigate the increased availability and low cost of foods that contribute to the obesity problem. Our objective was to test whether making the source of the health advice on the label more credible makes labelling more effective. METHODS AND MEASURES: Vending machines in different locations were stocked with healthy and unhealthy products in a hospital. Healthy products were randomly assigned to one of three conditions (i) a control condition in which no labelling was present (ii) a low source credibility label, "Lighter choices", and (iii) a high source credibility label that included the UK National Health Service (NHS) logo and name, "NHS lighter choices". Unhealthy products received no labelling. The outcome measure was sales volume. RESULTS: There were no main effects of labelling. However, there were significant interactions between labelling, vending machine location and payment type. For one location and payment type, sales of products increased in the high credibility label condition compared to control, particularly for unhealthy products, contrary to expectations. CONCLUSIONS: Our findings suggest that high source credibility health labels (NHS endorsement) on food either have little effect, or worse, can "backfire" and lead to effects opposite to those intended. The primary limitations are the limited range of source credibility labels and the scale of the study.

Declining global fertility rates and the implications for family planning and family building: an IFFS consensus document based on a narrative review of the literature.

BACKGROUND: Family-planning policies have focused on contraceptive approaches to avoid unintended pregnancies, postpone, or terminate pregnancies and mitigate population growth. These policies have contributed to significantly slowing world population growth. Presently, half the countries worldwide exhibit a fertility rate below replacement level. Not including the effects of migration, many countries are predicted to have a population decline of >50% from 2017 to 2100, causing demographic changes with profound societal implications. Policies that optimize chances to have a child when desired increase fertility rates and are gaining interest as a family-building method. Increasingly, countries have implemented child-friendly policies (mainly financial incentives in addition to public funding of fertility treatment in a limited number of countries) to mitigate decreasing national populations. However, the extent of public spending on child benefits varies greatly from country to country. To our knowledge, this International Federation of Fertility Societies (IFFS) consensus document represents the first attempt to describe major disparities in access to fertility care in the context of the global trend of decreasing growth in the world population, based on a narrative review of the existing literature. OBJECTIVE AND RATIONALE: The concept of family building, the process by which individuals or couples create or expand their families, has been largely ignored in family-planning paradigms. Family building encompasses various methods and options for individuals or couples who wish to have children. It can involve biological means, such as natural conception, as well as ART, surrogacy, adoption, and foster care. Family-building acknowledges the diverse ways in which individuals or couples can create their desired family and reflects the understanding that there is no one-size-fits-all approach to building a family. Developing education programs for young adults to increase family-building awareness and prevent infertility is urgently needed. Recommendations are provided and important knowledge gaps identified to provide professionals, the public, and policymakers with a comprehensive understanding of the role of child-friendly policies. SEARCH METHODS: A narrative review of the existing literature was performed by invited global leaders who themselves significantly contributed to this research field. Each section of the review was prepared by two to three experts, each of whom searched the published literature (PubMed) for peer reviewed full papers and reviews. Sections were discussed monthly by all authors and quarterly by the review board. The final document was prepared following discussions among all team members during a hybrid invitational meeting where full consensus was reached. OUTCOMES: Major advances in fertility care have dramatically improved family-building opportunities since the 1990s. Although up to 10% of all children are born as a result of fertility care in some wealthy countries, there is great variation in access to care. The high cost to patients of infertility treatment renders it unaffordable for most. Preliminary studies point to the increasing contribution of fertility care to the global population and the associated economic benefits for society. WIDER IMPLICATIONS: Fertility care has rarely been discussed in the context of a rapid decrease in world population growth. Soon, most countries will have an average number of children per woman far below the replacement level. While this may have a beneficial impact on the environment, underpopulation is of great concern in many countries. Although governments have implemented child-friendly policies, distinct discrepancies in access to fertility care remain.

A critical systematic review and meta-analyses of risk factors for fertility problems in a globalized world.

Globally, fertility awareness efforts include well-established risk factors for fertility problems. Risks disproportionately affecting women in the Global South, however, are neglected. To address this gap, we conducted a systematic review and meta-analyses of relevant risk factors to examine the association between risk factors and fertility problems. MEDLINE, Embase, Cochrane Library, regional databases and key organizational websites were used. Three authors screened and extracted data independently. Studies assessing exposure to risk (clinical, community-based samples) were included, and studies without control groups were excluded. Outcome of interest was fertility problems, e.g. inability to achieve pregnancy, live birth, neonatal death depending on study. The Newcastle-Ottawa Scale was used to assess study quality. A total of 3843 studies were identified, and 62 were included (58 in meta-analyses; n = 111,977). Results revealed the following: a ninefold risk of inability to become pregnant in genital tuberculosis (OR 8.91, 95% CI 1.89 to 42.12); an almost threefold risk in human immunodeficiency virus (OR 2.93, 95% CI 1.95 to 4.42) and bacterial vaginosis (OR 2.81, 95% CI 1.85 to 4.27); a twofold risk of tubal-factor infertility in female genital mutilation/cutting-Type II/III (OR 2.06, 95% CI 1.03 to 4.15); and postnatal mortality in consanguinity (stillbirth, OR 1.28, 95% CI 1.04 to 1.57; neonatal death, OR 1.57, 95% CI 1.22 to 2.02). It seems that risk factors affected reproductive processes through multiple pathways. Health promotion encompassing relevant health indicators could enhance prevention and early detection of fertility problems in the Global South and disproportionately affected populations. The multifactorial risk profile reinforces the need to place fertility within global health initiatives.

Breaking Boundaries: Toward Consistent Gender-Sensitive Language in Sexual and Reproductive Health Guidelines.

This review assesses gender-sensitive language in sexual and reproductive health (SRH) guidelines, including a guideline for polycystic ovary syndrome. We conducted a systematic search across databases like Medline, EMBASE, and Cochrane until July 31, 2023, using terms related to gender-inclusivity, SRH, and guideline protocols. Criteria for inclusion were gender-sensitive language, SRH focus, and guideline relevance, excluding non-English articles or those without policy considerations. Our search yielded 25 studies, with 6 included for qualitative synthesis. Results showed significant gaps in using gender-sensitive language in SRH guidelines. The debate on this language mirrors broader societal discourse. Recognizing gender diversity is essential for research, clinical practices, and societal norms. While promoting inclusion, drawbacks like unintended erasure or miscommunication should also be addressed. A gender-additive approach balances inclusivity and biological accuracy. Precise and inclusive discourse is crucial. Future research should focus on systemic approaches in the SRH sector.

The effect of an educational animation on knowledge of testicular health and fertility of adolescents.

STUDY QUESTION: Does the provision of an educational animation, developed with young people, about testicular health and fertility impact the knowledge of these topics among adolescents? SUMMARY ANSWER: The development and provision of education on testicular health and fertility were welcomed by adolescents and associated with a significant increase in knowledge. WHAT IS KNOWN ALREADY: Young people may know less than they should about testicular health and male fertility topics. Lack of knowledge can have implications for health including late medical help-seeking for signs and symptoms of scrotal disorders, such as torsion, for which late presentation frequently results in testicular damage. STUDY DESIGN, SIZE, DURATION: A mixed methods experimental pre- and post-design was used with embedded qualitative data collection. High school students completed a pre-animation questionnaire, watched four animations on testicular health and fertility, and completed a post-animation questionnaire. Data were collected during Personal Social and Health Education lessons across a 2-week period. PARTICIPANTS/MATERIALS, SETTING, METHODS: Four animations on testicular health and fertility, informed by andrologists, academics, designers, boys, and young men, were developed. Eligible participants were boys and girls in the UK school years 8 and 9 (age 13-14 years). Participants completed a Time 1 (T1) survey (fertility knowledge, demographics) prior to watching the animations and a Time 2 (T2) survey (fertility knowledge, perceptions of the animations) immediately after the animations. Perceptions were rated on 10-point response scales (higher scores better). Participants additionally expressed in their own words positive and negative aspects of the animations. ANOVA was used to examine the effects of the animations using a 2 (time: T1, T2)×2 (gender: male, female) design on topic knowledge, perceived importance, usefulness, and style of the animations according to gender. Regression analysis examined the associations between gender, disability, class year, and knowledge at T2 while controlling for knowledge at T1. Qualitative data on perceptions of the animations were analyzed using inductive thematic analysis. MAIN RESULTS AND THE ROLE OF CHANCE: Results showed that the animations significantly increased testicular health and fertility-related knowledge from T1 (x̄=41.84 ± 24.72) to T2 (x̄=79.15, ±15.04). Boys had significantly higher levels of knowledge compared to girls at T1 (x̄=44.74, SD = 25.16 versus x̄=37.79 ± 23.49, respectively) and T2 (x̄=80.07, SD = 15.68 versus x̄=77.89 ± 14.30, respectively) but knowledge gain from T1 to T2 was not significantly different according to gender (P = 0.11) as shown by non-significant gender×time interaction. There were no significant gender differences in the perceived usefulness and importance of the animations or liking of the style of the animations, with both genders considering the animations as useful, important, and likable. Regression analysis showed only knowledge at T1 to be significantly associated with knowledge at T2. Qualitative data showed three main themes: accessibility of important and useful information; information engagement and help-seeking behaviour; and inclusivity of information. LIMITATIONS, REASONS FOR CAUTION: This was a pre- and post-study with a sample of young people from a selected educational institution without a control group. Only short-term effects of the animations were recorded. WIDER IMPLICATIONS OF THE FINDINGS: Adolescents are interested in and learn from the provision of engaging fertility-related information. Boys and men should be considered as being a relevant target population for fertility education, not just girls and women. STUDY FUNDING/COMPETING INTEREST(S): This research was carried out in partnership with the British Fertility Society, was financially supported by an Economic and Social Research Council Impact Acceleration Award (520792) and commercial sponsorship from iMediCare Ltd, Bayer AG, Merck Group, Cryos International given to the British Fertility Society, and a financial contribution from Orchid Cancer Appeal. The authors are fully responsible for the content of the animations and this manuscript, and the views and opinions described in the publication reflect solely those of the authors. J.B. reports a grant from Merck Serono Ltd outside the submitted work. C.H., G.G., A.D., E.B., U.G., M.L, B.W., and M.H. declare no conflict of interest. K.M. reports honoraria from Bayer and Merck. A.P. reports paid consultancy for Cryos International, Cytoswim Ltd, Exceed Health, and Merck Serono in the last 2 years, but all monies have been paid to the University of Sheffield. TRIAL REGISTRATION NUMBER: N/A.

Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome†.

STUDY QUESTION: What is the recommended assessment and management of those with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference? SUMMARY ANSWER: International evidence-based guidelines address prioritized questions and outcomes and include 254 recommendations and practice points, to promote consistent, evidence-based care and improve the experience and health outcomes in PCOS. WHAT IS KNOWN ALREADY: The 2018 International PCOS Guideline was independently evaluated as high quality and integrated multidisciplinary and consumer perspectives from six continents; it is now used in 196 countries and is widely cited. It was based on best available, but generally very low to low quality, evidence. It applied robust methodological processes and addressed shared priorities. The guideline transitioned from consensus based to evidence-based diagnostic criteria and enhanced accuracy of diagnosis, whilst promoting consistency of care. However, diagnosis is still delayed, the needs of those with PCOS are not being adequately met, evidence quality was low and evidence-practice gaps persist. STUDY DESIGN, SIZE, DURATION: The 2023 International Evidence-based Guideline update reengaged the 2018 network across professional societies and consumer organizations, with multidisciplinary experts and women with PCOS directly involved at all stages. Extensive evidence synthesis was completed. Appraisal of Guidelines for Research and Evaluation-II (AGREEII)-compliant processes were followed. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength and diversity and inclusion were considered throughout. PARTICIPANTS/MATERIALS, SETTING, METHODS: This summary should be read in conjunction with the full Guideline for detailed participants and methods. Governance included a six-continent international advisory and management committee, five guideline development groups, and paediatric, consumer, and translation committees. Extensive consumer engagement and guideline experts informed the update scope and priorities. Engaged international society-nominated panels included paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, obesity care, public health and other experts, alongside consumers, project management, evidence synthesis, statisticians and translation experts. Thirty-nine professional and consumer organizations covering 71 countries engaged in the process. Twenty meetings and five face-to-face forums over 12 months addressed 58 prioritized clinical questions involving 52 systematic and 3 narrative reviews. Evidence-based recommendations were developed and approved via consensus across five guideline panels, modified based on international feedback and peer review, independently reviewed for methodological rigour, and approved by the Australian Government National Health and Medical Research Council (NHMRC). MAIN RESULTS AND THE ROLE OF CHANCE: The evidence in the assessment and management of PCOS has generally improved in the past five years, but remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpins 77 evidence-based and 54 consensus recommendations, with 123 practice points. Key updates include: i) further refinement of individual diagnostic criteria, a simplified diagnostic algorithm and inclusion of anti-Müllerian hormone (AMH) levels as an alternative to ultrasound in adults only; ii) strengthening recognition of broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnea, very high prevalence of psychological features, and high risk status for adverse outcomes during pregnancy; iii) emphasizing the poorly recognized, diverse burden of disease and the need for greater healthcare professional education, evidence-based patient information, improved models of care and shared decision making to improve patient experience, alongside greater research; iv) maintained emphasis on healthy lifestyle, emotional wellbeing and quality of life, with awareness and consideration of weight stigma; and v) emphasizing evidence-based medical therapy and cheaper and safer fertility management. LIMITATIONS, REASONS FOR CAUTION: Overall, recommendations are strengthened and evidence is improved, but remains generally low to moderate quality. Significantly greater research is now needed in this neglected, yet common condition. Regional health system variation was considered and acknowledged, with a further process for guideline and translation resource adaptation provided. WIDER IMPLICATIONS OF THE FINDINGS: The 2023 International Guideline for the Assessment and Management of PCOS provides clinicians and patients with clear advice on best practice, based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the Guideline with an integrated evaluation program. STUDY FUNDING/COMPETING INTEREST(S): This effort was primarily funded by the Australian Government via the National Health Medical Research Council (NHMRC) (APP1171592), supported by a partnership with American Society for Reproductive Medicine, Endocrine Society, European Society for Human Reproduction and Embryology, and European Society for Endocrinology. The Commonwealth Government of Australia also supported Guideline translation through the Medical Research Future Fund (MRFCRI000266). HJT and AM are funded by NHMRC fellowships. JT is funded by a Royal Australasian College of Physicians (RACP) fellowship. Guideline development group members were volunteers. Travel expenses were covered by the partnering organizations. Disclosures of interest were strictly managed according to NHMRC policy and are available with the full guideline, technical evidence report, peer review and responses (www.monash.edu/medicine/mchri/pcos). Of named authors HJT, CTT, AD, LM, LR, JBoyle, AM have no conflicts of interest to declare. JL declares grant from Ferring and Merck; consulting fees from Ferring and Titus Health Care; speaker's fees from Ferring; unpaid consultancy for Ferring, Roche Diagnostics and Ansh Labs; and sits on advisory boards for Ferring, Roche Diagnostics, Ansh Labs, and Gedeon Richter. TP declares a grant from Roche; consulting fees from Gedeon Richter and Organon; speaker's fees from Gedeon Richter and Exeltis; travel support from Gedeon Richter and Exeltis; unpaid consultancy for Roche Diagnostics; and sits on advisory boards for Roche Diagnostics. MC declares travels support from Merck; and sits on an advisory board for Merck. JBoivin declares grants from Merck Serono Ltd.; consulting fees from Ferring B.V; speaker's fees from Ferring Arzneimittell GmbH; travel support from Organon; and sits on an advisory board for the Office of Health Economics. RJN has received speaker's fees from Merck and sits on an advisory board for Ferring. AJoham has received speaker's fees from Novo Nordisk and Boehringer Ingelheim. The guideline was peer reviewed by special interest groups across our 39 partner and collaborating organizations, was independently methodologically assessed against AGREEII criteria and was approved by all members of the guideline development groups and by the NHMRC.

Recommendations From the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome.

STUDY QUESTION: What is the recommended assessment and management of those with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference? SUMMARY ANSWER: International evidence-based guidelines address prioritized questions and outcomes and include 254 recommendations and practice points, to promote consistent, evidence-based care and improve the experience and health outcomes in PCOS. WHAT IS KNOWN ALREADY: The 2018 International PCOS Guideline was independently evaluated as high quality and integrated multidisciplinary and consumer perspectives from six continents; it is now used in 196 countries and is widely cited. It was based on best available, but generally very low to low quality, evidence. It applied robust methodological processes and addressed shared priorities. The guideline transitioned from consensus based to evidence-based diagnostic criteria and enhanced accuracy of diagnosis, whilst promoting consistency of care. However, diagnosis is still delayed, the needs of those with PCOS are not being adequately met, evidence quality was low and evidence-practice gaps persist. STUDY DESIGN, SIZE, DURATION: The 2023 International Evidence-based Guideline update reengaged the 2018 network across professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Extensive evidence synthesis was completed. Appraisal of Guidelines for Research and Evaluation-II (AGREEII)-compliant processes were followed. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength and diversity and inclusion were considered throughout. PARTICIPANTS/MATERIALS, SETTING, METHODS: This summary should be read in conjunction with the full Guideline for detailed participants and methods. Governance included a six-continent international advisory and management committee, five guideline development groups, and paediatric, consumer, and translation committees. Extensive consumer engagement and guideline experts informed the update scope and priorities. Engaged international society-nominated panels included paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, obesity care, public health and other experts, alongside consumers, project management, evidence synthesis, statisticians and translation experts. Thirty-nine professional and consumer organizations covering 71 countries engaged in the process. Twenty meetings and five face-to-face forums over 12 months addressed 58 prioritized clinical questions involving 52 systematic and 3 narrative reviews. Evidence-based recommendations were developed and approved via consensus across five guideline panels, modified based on international feedback and peer review, independently reviewed for methodological rigour, and approved by the Australian Government National Health and Medical Research Council (NHMRC). MAIN RESULTS AND THE ROLE OF CHANCE: The evidence in the assessment and management of PCOS has generally improved in the past five years, but remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpins 77 evidence-based and 54 consensus recommendations, with 123 practice points. Key updates include: i) further refinement of individual diagnostic criteria, a simplified diagnostic algorithm and inclusion of anti-Müllerian hormone (AMH) levels as an alternative to ultrasound in adults only; ii) strengthening recognition of broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnea, very high prevalence of psychological features, and high risk status for adverse outcomes during pregnancy; iii) emphasizing the poorly recognized, diverse burden of disease and the need for greater healthcare professional education, evidence-based patient information, improved models of care and shared decision making to improve patient experience, alongside greater research; iv) maintained emphasis on healthy lifestyle, emotional wellbeing and quality of life, with awareness and consideration of weight stigma; and v) emphasizing evidence-based medical therapy and cheaper and safer fertility management. LIMITATIONS, REASONS FOR CAUTION: Overall, recommendations are strengthened and evidence is improved, but remain generally low to moderate quality. Significantly greater research is now needed in this neglected, yet common condition. Regional health system variation was considered and acknowledged, with a further process for guideline and translation resource adaptation provided. WIDER IMPLICATIONS OF THE FINDINGS: The 2023 International Guideline for the Assessment and Management of PCOS provides clinicians and patients with clear advice on best practice, based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation programme supports the Guideline with an integrated evaluation program. STUDY FUNDING/COMPETING INTEREST(S): This effort was primarily funded by the Australian Government via the National Health Medical Research Council (NHMRC) (APP1171592), supported by a partnership with American Society for Reproductive Medicine, Endocrine Society, European Society for Human Reproduction and Embryology, and the European Society for Endocrinology. The Commonwealth Government of Australia also supported Guideline translation through the Medical Research Future Fund (MRFCRI000266). HJT and AM are funded by NHMRC fellowships. JT is funded by a Royal Australasian College of Physicians (RACP) fellowship. Guideline development group members were volunteers. Travel expenses were covered by the sponsoring organizations. Disclosures of interest were strictly managed according to NHMRC policy and are available with the full guideline, technical evidence report, peer review and responses (www.monash.edu/medicine/mchri/pcos). Of named authors HJT, CTT, AD, LM, LR, JBoyle, AM have no conflicts of interest to declare. JL declares grant from Ferring and Merck; consulting fees from Ferring and Titus Health Care; speaker's fees from Ferring; unpaid consultancy for Ferring, Roche Diagnostics and Ansh Labs; and sits on advisory boards for Ferring, Roche Diagnostics, Ansh Labs, and Gedeon Richter. TP declares a grant from Roche; consulting fees from Gedeon Richter and Organon; speaker's fees from Gedeon Richter and Exeltis; travel support from Gedeon Richter and Exeltis; unpaid consultancy for Roche Diagnostics; and sits on advisory boards for Roche Diagnostics. MC declares travels support from Merck; and sits on an advisory board for Merck. JBoivin declares grants from Merck Serono Ltd.; consulting fees from Ferring B.V; speaker's fees from Ferring Arzneimittell GmbH; travel support from Organon; and sits on an advisory board for the Office of Health Economics. RJN has received speaker's fees from Merck and sits on an advisory board for Ferring. AJoham has received speaker's fees from Novo Nordisk and Boehringer Ingelheim. The guideline was peer reviewed by special interest groups across our 39 partner and collaborating organizations, was independently methodologically assessed against AGREEII criteria and was approved by all members of the guideline development groups and by the NHMRC.

Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome.

STUDY QUESTION: What is the recommended assessment and management of those with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference? SUMMARY ANSWER: International evidence-based guidelines address prioritized questions and outcomes and include 254 recommendations and practice points, to promote consistent, evidence-based care and improve the experience and health outcomes in PCOS. WHAT IS KNOWN ALREADY: The 2018 International PCOS Guideline was independently evaluated as high quality and integrated multidisciplinary and consumer perspectives from six continents; it is now used in 196 countries and is widely cited. It was based on best available, but generally very low to low quality, evidence. It applied robust methodological processes and addressed shared priorities. The guideline transitioned from consensus based to evidence-based diagnostic criteria and enhanced accuracy of diagnosis, whilst promoting consistency of care. However, diagnosis is still delayed, the needs of those with PCOS are not being adequately met, evidence quality was low and evidence-practice gaps persist. STUDY DESIGN, SIZE, DURATION: The 2023 International Evidence-based Guideline update reengaged the 2018 network across professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Extensive evidence synthesis was completed. Appraisal of Guidelines for Research and Evaluation-II (AGREEII)-compliant processes were followed. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength and diversity and inclusion were considered throughout. PARTICIPANTS/ MATERIALS, SETTING, METHODS: This summary should be read in conjunction with the full Guideline for detailed participants and methods. Governance included a six-continent international advisory and management committee, five guideline development groups, and paediatric, consumer, and translation committees. Extensive consumer engagement and guideline experts informed the update scope and priorities. Engaged international society-nominated panels included paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, obesity care, public health and other experts, alongside consumers, project management, evidence synthesis, statisticians and translation experts. Thirty-nine professional and consumer organizations covering 71 countries engaged in the process. Twenty meetings and five face-to-face forums over 12 months addressed 58 prioritized clinical questions involving 52 systematic and 3 narrative reviews. Evidence-based recommendations were developed and approved via consensus across five guideline panels, modified based on international feedback and peer review, independently reviewed for methodological rigour, and approved by the Australian Government National Health and Medical Research Council (NHMRC). MAIN RESULTS AND THE ROLE OF CHANCE: The evidence in the assessment and management of PCOS has generally improved in the past five years, but remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpins 77 evidence-based and 54 consensus recommendations, with 123 practice points. Key updates include: i) further refinement of individual diagnostic criteria, a simplified diagnostic algorithm and inclusion of anti-Müllerian hormone (AMH) levels as an alternative to ultrasound in adults only; ii) strengthening recognition of broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnea, very high prevalence of psychological features, and high risk status for adverse outcomes during pregnancy; iii) emphasizing the poorly recognized, diverse burden of disease and the need for greater healthcare professional education, evidence-based patient information, improved models of care and shared decision making to improve patient experience, alongside greater research; iv) maintained emphasis on healthy lifestyle, emotional wellbeing and quality of life, with awareness and consideration of weight stigma; and v) emphasizing evidence-based medical therapy and cheaper and safer fertility management. LIMITATIONS, REASONS FOR CAUTION: Overall, recommendations are strengthened and evidence is improved, but remain generally low to moderate quality. Significantly greater research is now needed in this neglected, yet common condition. Regional health system variation was considered and acknowledged, with a further process for guideline and translation resource adaptation provided. WIDER IMPLICATIONS OF THE FINDINGS: The 2023 International Guideline for the Assessment and Management of PCOS provides clinicians and patients with clear advice on best practice, based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation programme supports the Guideline with an integrated evaluation program. STUDY FUNDING/COMPETING INTEREST(S): This effort was primarily funded by the Australian Government via the National Health Medical Research Council (NHMRC) (APP1171592), supported by a partnership with American Society for Reproductive Medicine, Endocrine Society, European Society for Human Reproduction and Embryology, and the Society for Endocrinology. The Commonwealth Government of Australia also supported Guideline translation through the Medical Research Future Fund (MRFCRI000266). HJT and AM are funded by NHMRC fellowships. JT is funded by a Royal Australasian College of Physicians (RACP) fellowship. Guideline development group members were volunteers. Travel expenses were covered by the sponsoring organizations. Disclosures of interest were strictly managed according to NHMRC policy and are available with the full guideline, technical evidence report, peer review and responses (www.monash.edu/medicine/mchri/pcos). Of named authors HJT, CTT, AD, LM, LR, JBoyle, AM have no conflicts of interest to declare. JL declares grant from Ferring and Merck; consulting fees from Ferring and Titus Health Care; speaker's fees from Ferring; unpaid consultancy for Ferring, Roche Diagnostics and Ansh Labs; and sits on advisory boards for Ferring, Roche Diagnostics, Ansh Labs, and Gedeon Richter. TP declares a grant from Roche; consulting fees from Gedeon Richter and Organon; speaker's fees from Gedeon Richter and Exeltis; travel support from Gedeon Richter and Exeltis; unpaid consultancy for Roche Diagnostics; and sits on advisory boards for Roche Diagnostics. MC declares travels support from Merck; and sits on an advisory board for Merck. JBoivin declares grants from Merck Serono Ltd.; consulting fees from Ferring B.V; speaker's fees from Ferring Arzneimittell GmbH; travel support from Organon; and sits on an advisory board for the Office of Health Economics. RJN has received speaker's fees from Merck and sits on an advisory board for Ferring. AJoham has received speaker's fees from Novo Nordisk and Boehringer Ingelheim. The guideline was peer reviewed by special interest groups across our 39 partner and collaborating organizations, was independently methodologically assessed against AGREEII criteria and was approved by all members of the guideline development groups and by the NHMRC.

Recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome.

STUDY QUESTION: What is the recommended assessment and management of those with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference? SUMMARY ANSWER: International evidence-based guidelines address prioritized questions and outcomes and include 254 recommendations and practice points, to promote consistent, evidence-based care and improve the experience and health outcomes in PCOS. WHAT IS KNOWN ALREADY: The 2018 International PCOS Guideline was independently evaluated as high quality and integrated multidisciplinary and consumer perspectives from 6 continents; it is now used in 196 countries and is widely cited. It was based on best available, but generally very low- to low-quality, evidence. It applied robust methodological processes and addressed shared priorities. The guideline transitioned from consensus-based to evidence-based diagnostic criteria and enhanced accuracy of diagnosis, whilst promoting consistency of care. However, diagnosis is still delayed, the needs of those with PCOS are not being adequately met, the evidence quality was low, and evidence-practice gaps persist. STUDY DESIGN, SIZE, AND DURATION: The 2023 International Evidence-based Guideline update re-engaged the 2018 network across professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Extensive evidence synthesis was completed. Appraisal of Guidelines for Research and Evaluation II (AGREEII)-compliant processes were followed. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation, and ultimately recommendation strength, and diversity and inclusion were considered throughout. PARTICIPANTS/MATERIALS, SETTING, AND METHODS: This summary should be read in conjunction with the full guideline for detailed participants and methods. Governance included a 6-continent international advisory and management committee, 5 guideline development groups, and paediatric, consumer, and translation committees. Extensive consumer engagement and guideline experts informed the update scope and priorities. Engaged international society-nominated panels included paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, obesity care, public health, and other experts, alongside consumers, project management, evidence synthesis, statisticians, and translation experts. Thirty-nine professional and consumer organizations covering 71 countries engaged in the process. Twenty meetings and 5 face-to-face forums over 12 months addressed 58 prioritized clinical questions involving 52 systematic and 3 narrative reviews. Evidence-based recommendations were developed and approved via consensus across 5 guideline panels, modified based on international feedback and peer review, independently reviewed for methodological rigour, and approved by the Australian Government National Health and Medical Research Council. MAIN RESULTS AND THE ROLE OF CHANCE: The evidence in the assessment and management of PCOS has generally improved in the past 5 years but remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpin 77 evidence-based and 54 consensus recommendations, with 123 practice points. Key updates include the following: (1) further refinement of individual diagnostic criteria, a simplified diagnostic algorithm, and inclusion of anti-Müllerian hormone levels as an alternative to ultrasound in adults only; (2) strengthening recognition of broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnoea, very high prevalence of psychological features, and high risk status for adverse outcomes during pregnancy; (3) emphasizing the poorly recognized, diverse burden of disease and the need for greater healthcare professional education, evidence-based patient information, improved models of care, and shared decision-making to improve patient experience, alongside greater research; (4) maintained emphasis on healthy lifestyle, emotional well-being, and quality of life, with awareness and consideration of weight stigma; and (5) emphasizing evidence-based medical therapy and cheaper and safer fertility management. LIMITATIONS AND REASONS FOR CAUTION: Overall, recommendations are strengthened and evidence is improved but remains generally low to moderate quality. Significantly greater research is now needed in this neglected, yet common condition. Regional health system variation was considered and acknowledged, with a further process for guideline and translation resource adaptation provided. WIDER IMPLICATIONS OF THE FINDINGS: The 2023 International Guideline for the Assessment and Management of PCOS provides clinicians and patients with clear advice on best practice, based on the best available evidence, expert multidisciplinary input, and consumer preferences. Research recommendations have been generated, and a comprehensive multifaceted dissemination and translation programme supports the guideline with an integrated evaluation programme.

A systematic review of models of care for polycystic ovary syndrome highlights the gap in the literature, especially in developing countries.

Introduction: The aim of the study was to identify available polycystic ovary syndrome (PCOS) models of care (MoCs) and describe their characteristics and alignment with the international PCOS guideline. Methods: Ovid MEDLINE, All EBM, PsycINFO, Embase, and CINAHL were searched from inception until 11 July 2022. Any study with a description of a PCOS MoC was included. Non-evidence-based guidelines, abstracts, study protocols, and clinical trial registrations were excluded. We also excluded MoCs delivered in research settings to minimize care bias. Meta-analysis was not performed due to heterogeneity across MoCs. We describe and evaluate each MoC based on the recommendations made by the international evidence-based guideline for assessing and managing PCOS. Results: Of 3,671 articles, six articles describing five MoCs were included in our systematic review. All MoCs described a multidisciplinary approach, including an endocrinologist, dietitian, gynecologist, psychologist, dermatologist, etc. Three MoCs described all aspects of PCOS care aligned with the international guideline recommendations. These include providing education on long-term risks, lifestyle interventions, screening and management of emotional well-being, cardiometabolic diseases, and the dermatological and reproductive elements of PCOS. Three MoCs evaluated patients' and healthcare professionals' satisfaction, with generally positive findings. Only one MoC explored the impact of their service on patients' health outcomes and showed improvement in BMI. Conclusion: There is limited literature describing PCOS MoCs in routine practice. Future research should explore developing cost-effective co-created multidisciplinary PCOS MoCs globally. This may be facilitated by the exchange of best practices between institutions with an established MoC and those who are interested in setting one up. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=346539, identifier CRD42022346539.

Unmet Parenthood Goals, Health-Related Quality of Life and Apparent Irrationality: Understanding the Value of Treatments for Infertility.

An increasing number of prospective parents are experiencing infertility along with associated negative impacts on mental health and life satisfaction that can extend across a network of individuals and family members. Assistive reproductive technologies (ART) can help prospective parents achieve their parenthood goals but, like any health technology, they must demonstrate acceptable 'value for money' to qualify for public funding. We argue that current approaches to understanding the value of ART, including quality-adjusted life-year (QALY) gains based on changes in health-related quality of life (HRQOL) and, more often, cost per live birth, are too narrow to capture the full impact of unmet parenthood goals and ART. We see a fundamental disconnect between measures of HRQOL and broader measures of wellbeing associated with met and unmet parenthood goals. We also suggest that simple concepts such as 'patient' and 'carer' are of limited applicability in the context of ART, where 'spillovers' extend across a wide network of individuals, and the person receiving treatment is often not the infertile individual. Consideration of individual and societal wellbeing beyond HRQOL is necessary to understand the full range of negative impacts associated with unmet parenthood goals and the corresponding positive impacts of successful ART. We suggest moving towards a wellbeing perspective on value to achieve a fuller understanding of value and promote cross-sector allocative efficiency.

Emotional reactions to infertility diagnosis: thematic and natural language processing analyses of the 1000 Dreams survey.

RESEARCH QUESTION: What are the emotional effects of infertility on patients, partners, or both, and how can qualitative thematic analyses and natural language processing (NLP) help evaluate textual data? DESIGN: A cross-sectional, multi-country survey conducted between March 2019 and May 2019. A total of 1944 patients, partners, or both, from nine countries responded to the open-ended question asking about their initial feelings related to an infertility diagnosis. A mixed-method approach that integrated NLP topic modelling and thematic analyses was used to analyse responses. Sentiment polarity was quantified for each response. Linear regression evaluated the association between patient characteristics and sentiment negativity. RESULTS: Common emotional reactions to infertility diagnoses were sadness, depression, stress, disappointment, anxiety, frustration, confusion and loss of self-confidence. NLP topic modelling found additional reactions, i.e. shared feelings with partners, recollections about causes of infertility and treatment experience. Responses to the open-ended question were brief (median: three words) with 71.8% conveying negative sentiments. Some respondent characteristics showed small but significant associations with sentiment negativity, i.e. country (Spain, China and France were more negative than the USA, P < 0.001, P < 0.003 and P < 0.009 respectively), treatment engagement (no treatment was more negative than one or more treatment, P = 0.027) and marital status (missing/other was more negative than divorced, P = 0.003). CONCLUSION: Infertility diagnoses create an emotional burden for patients and partners. The mixed-method approach provides a compelling synergy in support of the validity of these findings and shows potential for these techniques in future research.

COVID-19-related uncertainty: fertility staff experiences of its sources, processing, responses, and consequences.

STUDY QUESTION: What are fertility staff experiences of managing COVID-19-related uncertainty after fertility clinics re-opened? SUMMARY ANSWER: Staff identified many COVID-19-related uncertainty sources, the main being the COVID-19 health threat, to which most clinics and staff responded effectively by implementing safety protocols and building strong collaborative environments that facilitated the acquisition and application of information to guide organizational responses during a rapidly changing situation, but with costs for staff and patients. WHAT IS KNOWN ALREADY: COVID-19 created significant disruption in fertility care delivery, including temporary clinic closure and treatment delay. Patients experienced significant distress, including concerns regarding the impact of COVID-19 and its vaccine on fertility and pregnancy. Multiple studies show that COVID-19-related uncertainty is a major threat and burden for healthcare staff, but this has not been investigated in reproductive medicine. STUDY DESIGN, SIZE, DURATION: A cross-sectional, online mixed-method bilingual (English, Spanish) survey (active 25 January-23 May 2021) was distributed to fertility staff across the UK, Latin America, and Africa. PARTICIPANTS/MATERIALS, SETTING, METHODS: Eligibility criteria were being a healthcare worker at a fertility clinic that had re-opened since its COVID-19-related closure, 18 years of age or older and ability to respond in English or Spanish. The survey was created in English, translated to Spanish, made available using Qualtrics, and consisted of four parts: (i) background and physical and mental wellbeing, (ii) open-ended questions regarding COVID-19 uncertainty, (iii) appraisal items regarding perceptions and impact of uncertainty, and (iv) changes in the workplace. The British Fertility Society and the African Network and Registry of Assisted Reproduction circulated the survey across the UK and Africa via email hyperlinks and social media platforms. The Argentinian Society of Reproductive Medicine and the Latin American Network of Assisted Reproduction distributed the survey across Latin America in the same manner. Thematic analysis was performed on responses from open-ended question to produce basic codes. Deductive coding grouped sub-themes across questions into themes related to the theory of uncertainty management. Descriptive statistics and repeated measures analysis of variance were used on the quantitative data. MAIN RESULTS AND THE ROLE OF CHANCE: In total, 382 staff consented to the survey, 107 did not complete (28% attrition), and 275 completed. Sixty-three percent were women, 69% were physicians, and 79% worked at private clinics. Thematic analysis produced 727 codes, organized in 92 sub-themes, and abstracted into 18 themes and one meta-theme reflecting that uncertainty is stressful but manageable. The types of uncertainties related to the threat of COVID-19 (20.6%), unpredictability of the future (19.5%), failure of communication (11.4%), and change in the workplace (8.4%). Staff appraisals of negative and positive impact of uncertainty were significantly lower (P < 0.001) than appraisals of stress, controllability, and having what it takes to cope with uncertainty. To process uncertainty, clinics focused on information dissemination (30.8%) and building a collaborative work environment (5.8%), while staff employed proactive coping (41.8%) and emotional and cognitive processing (9.6%). Main organizational responses consisted on work restructuring (41.3%, e.g. safety protocols), adapting to adversity (9.5%, e.g. supplies, preparation), and welfare support (13.8%), though staff perceived lack of support (17.5%). Negative consequences of uncertainty were worse self- and patient welfare (12.1%) and worse communication due to virtual medicine and use of mask (9.6%). Positive consequences were work improvements (8.3%), organizational adaptation (8.3%), improved relationships (5.6%), and individual adaptation (3.2%). Ninety-two percent of participants thought changes experienced in the workplace due to COVID-19 were negative, 9.1% nor negative nor positive, and 14.9% positive. Most staff thought that their physical (92.4%) and mental health (89.5%) were good to excellent. LIMITATIONS, REASONS FOR CAUTION: Participants were self-selected, and most were physicians and embryologists working at private clinics based in Latin America. The study did not account for how variability in national and regional COVID-19 policy shaped staff experiences of uncertainty. WIDER IMPLICATIONS OF THE FINDINGS: To address COVID-19 uncertainty, clinics need to promote collaborative (clinic, staff, patients) processing of uncertainty, clear team coordination and communication, organizational flexibility, and provision of support to staff and patients, with an emphasis on cognitive coping to decrease threat of and increase tolerance to uncertainty. Uncertainty management interventions bespoke to fertility care that integrate these components may increase clinics resilience to COVID-19-related and other types of uncertainty. STUDY FUNDING/COMPETING INTERESTS: Cardiff University funded this research. S.G. reports consultancy fees from Ferring Pharmaceuticals A/S, speaker fees from Access Fertility, SONA-Pharm LLC, Meridiano Congress International, and Gedeon Richter, and grants from Merck Serono Ltd. F.Z.-H. reports speaker fees from Ferring Pharmaceuticals A/S and that he is a chair of the Latin American Registry of ART, Committee of Ethic and Public Policies, and Chilean Society of Obstetrics and Gynecology and a vice chair of the International Committee for monitoring ART. K.A., N.C., G.B., and J.B. report no conflict in relation to this work. TRIAL REGISTRATION NUMBER: N/A.

Tailored support may reduce mental and relational impact of infertility on infertile patients and partners.

RESEARCH QUESTION: What is the psychological impact of infertility on infertile patients and partners of infertile patients? DESIGN: This online, international, quantitative survey assessed the impact of infertility on mental health, relationships and daily activities for 1944 respondents. Respondents were male or female infertile patients (n = 1037) or partners to infertile patients (n = 907; not necessarily partners of the patient sample) and were recruited at different stages of the treatment journey. RESULTS: The most common emotions were 'sadness' at infertility diagnosis and 'anxiety' during treatment. Emotions differed in nature and intensity throughout the journey. Envy of others who achieved pregnancy was frequently reported by women. More than half of respondents (60.4%; n = 1174) perceived the infertility journey to have impacted their mental health, and 44.1% (n = 857) of respondents sought mental health support. More patients reported mental health impacts (70.1%, n = 727) than partners (49.3%, n = 447). One in three respondents indicated that their relationship had suffered due to the infertility diagnosis. Of these respondents, 55.0% (n = 409) strongly agreed that infertility caused an emotional strain. Patients more often than partners reported a detrimental impact on daily activities. Respondents most commonly agreed with statements regarding an 'effect on work-life balance'. CONCLUSION: Treatment journey stages are defined by their impact profile, which differs between infertile patients and partners of infertile patients. Negative impacts are diverse (mental health, relational, daily activities). There was disparity between the number of respondents reporting mental health issues and the number seeking mental health support. This indicates the need for support services tailored to different treatment stages.

Effect of fertility health awareness strategies on fertility knowledge and childbearing in young married couples (FertStart): study protocol for an effectiveness-implementation hybrid type I multicentre three-arm parallel group open-label randomised clinical trial.

INTRODUCTION: Birth rates have been declining in many advanced societies including Singapore. We designed two interventions with vastly different resource requirements, which include fertility education, personalised fertility information and a behavioural change component targeting modifiable psychological constructs to modify fertility awareness and childbearing intentions. We aim to evaluate the effect of these two interventions on knowledge, attitudes and practice around childbearing compared with a control group among young married couples in Singapore and understand the implementation factors in the setting of an effectiveness-implementation hybrid type 1 three-arm randomised trial. METHODS AND ANALYSIS: We will randomise 1200 young married couples to no intervention (control), Fertility Health Screening group (FHS) or Fertility Awareness Tools (FAT) in a 7:5:5 ratio. Couples in FHS will undergo an anti-Mullerian hormone test and semen analysis, a doctor's consultation to explain the results and standardised reproductive counselling by a trained nurse. Couples in FAT will watch a standardised video, complete an adapted fertility status awareness (FertiSTAT) tool and receive an educational brochure. The attitudes, fertility knowledge and efforts to achieve pregnancy of all couples will be assessed at baseline and 6 months post-randomisation. Birth statistics will be tracked using administrative records at 2 and 3 years. The primary outcome is the change in the woman's self-reported intended age at first birth between baseline and 6 months post-randomisation. In addition, implementation outcomes and cost-effectiveness of the two interventions will be assessed. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the Centralized Institutional Review Board of SingHealth (2019/2095). Study results will be reported to the study funder and there are plans to disseminate them in scientific conferences and publications, where authorship will be determined by the International Committee of Medical Journal Editors guidelines. TRIAL REGISTRATION NUMBER: NCT04647136; ClinicalTrails.gov Identifier.

The impact of pharaonic female genital mutilation on sexuality: Two cases from Sudan highlighting the need for widespread dissemination of sexual and reproductive health education in Africa.

It is well documented that female genital mutilation (FGM) can have numerous physical and psychosocial consequences. The increased awareness about FGM and its impact on female health over the past few decades has led to a ban on FGM in many countries, however, this has yet to translate into measurable changes in prevalence. Efforts to enforce legislation have been unsuccessful in part because the general public lacks information about the negative consequences of FGM. In this report we present two cases of sexual difficulties as a result of FGM from Sudan, where the most severe form of FGM is still being practiced. During an interview about infertility, these two women volunteered information about how FGM has affected their sexuality. The lack of information about the impact of FGM on sexuality reflected in these cases, highlighted the significant need for widespread dissemination of sexual and reproductive health education in Africa.

The importance of the 'family clock': women's lived experience of fertility decision-making 6 years after attending the Fertility Assessment and Counselling Clinic.

This study explored women's lived experience of making fertility decisions six years after attending the Fertility Assessment and Counselling (FAC) clinic in Copenhagen, Denmark, which is a personalised fertility awareness intervention. We conducted a qualitative interview study with 24 women who attended the FAC clinic 6 years earlier. Interviews were semi-structured and broadly examined the women's perceptions and experience of the intervention during follow-up. Data was analysed using a phenomenological framework and themes were identified related to women's experience of making fertility decisions after attending the FAC clinic. The overarching theme regarding the women's lived experience of making fertility decisions after attending the FAC clinic was: Fertility decisions were guided by the 'family clock'. There were four themes: (i) Deciding to 'get started' by attending the FAC clinic; (ii) Sense of making informed and empowered decisions; (iii) Influence of partner status on fertility decisions; and (iv) Decisions dictated by circumstance over preference and knowledge. At follow-up, the majority (21 women, 88%) had become parents. More than half of the women said that they had not achieved their desired family size. Consideration of women's 'family clock' is necessary in personalised fertility awareness interventions to enable women to achieve their family goals.