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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., Competing Interests: Conflict of Interest Disclosures of interest were declared at the outset and updated throughout the guideline process, aligned with National Health Medical Research Council (NHMRC) guideline processes. These are available online (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., (Copyright © 2023. Published by Elsevier Inc.)

Objective: To examine construct and criterion validity of the Dutch SCREENIVF among women and men undergoing a fertility treatment., Design: A prospective longitudinal study nested in a randomized controlled trial., Setting: University hospital., Patient(s): Couples, 468 women and 383 men, undergoing an IVF/intracytoplasmic sperm injection (ICSI) treatment in a fertility clinic, completed the SCREENIVF., Main Outcome Measure(s): Construct and criteria validity of the SCREENIVF., Result(s): The comparative fit index and root mean square error of approximation for women and men show a good fit of the factor model. Across time, the sensitivity for Hospital Anxiety and Depression Scale subscale in women ranged from 61%-98%, specificity 53%-65%, predictive value of a positive test (PVP) 13%-56%, predictive value of a negative test (PVN) 70%-99%. The sensitivity scores for men ranged from 38%-100%, specificity 71%-75%, PVP 9%-27%, PVN 92%-100%. A prediction model revealed that for women 68.7% of the variance in the Hospital Anxiety and Depression Scale on time 1 and 42.5% at time 2 and 38.9% at time 3 was explained by the predictors, the sum score scales of the SCREENIVF. For men, 58.1% of the variance in the Hospital Anxiety and Depression Scale on time 1 and 46.5% at time 2 and 37.3% at time 3 was explained by the predictors, the sum score scales of the SCREENIVF., Conclusion(s): The SCREENIVF has good construct validity but the concurrent validity is better than the predictive validity. SCREENIVF will be most effectively used in fertility clinics at the start of treatment and should not be used as a predictive tool., (Copyright © 2017 American Society for Reproductive Medicine. All rights reserved.)

Five key paradigm shifts are described to illustrate the evolution of psychology and counseling in infertility. The first paradigm shift was in the 1930s when psychosomatic concepts were introduced in obstetrics and gynecology as causal factors to explain why some couples could not conceive despite the absence of organic pathology. In the second shift, the nurse advocacy movement of the 1970s stimulated the investigation of the psychosocial consequences of infertility and promoted counseling to help couples grieve childlessness when medical treatments often could not help them conceive. The third shift occurred with the advent of IVF, which created a demand for mental health professionals in fertility clinics. Mental health professionals assessed the ability of couples to withstand the demands of this new high technology treatment as well as their suitability as potential parents. The fourth shift, in the 1990s, saw reproductive medicine embrace the principles of evidence-based medicine, which introduced a much more rigorous approach to medical practice (effectiveness and safety) that extended to psychosocial interventions. The most recent paradigm shift, in the new millennium, occurred with the realization that compliance with protracted fertility treatment depended on the adoption of an integrated approach to fertility care. An integrated approach could reduce treatment burden arising from multiple sources (i.e., patient, clinic, and treatment). This review describes these paradigm shifts and reflects on future clinical and research directions for mental health professionals., (Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To determine whether a brief self-administered cognitive coping and relaxation intervention (CCRI) would lead to decreased treatment termination in in vitro fertilization (IVF) patients compared with routine care (RC)., Design: Randomized, controlled, prospective study., Setting: Private academically affiliated infertility center., Patient(s): One hundred sixty-six women about to begin their first IVF cycle., Intervention(s): Randomization to the self-administered CCRI or RC control group and then observation for 12 months., Main Outcome Measure(s): Treatment discontinuation within 12 months (primary outcome), clinical pregnancy rate and psychological well-being (secondary outcomes)., Result(s): The 12-month pregnancy rate was similar for the RC and CCRI groups (odds ratio [OR] 1.02; 95% CI, 0.53-1.98). Of the patients who were not pregnant on the first cycle, 15 of 46 (15.2%) patients assigned to RC discontinued compared with 5 of 55 (5.5%) patients assigned to the CCRI (OR 3.11; 95% CI, 0.756-12.80). The CCRI group engaged in statistically significantly more positive reappraisal coping (OR 0.275; 95% CI, 0.16, 0.39) than the RC control group (OR 0.097; 95% CI, -0.03, .23). The CCRI group had an improved Fertility Quality of Life (FertiQoL CORE: OR 4.07; 95% CI, 2.07, 6.06; FertiQoL Emotional: OR 5.95; 95% CI, 2.89, 9.00) compared with the control group (Core OR: 0.67; 95% CI, -1.55, 2.89; Emotional: OR -0.02, 95% CI, -3.36, 3.32). The CCRI group reported less global anxiety (OR 0.275; 95% CI, 0.16, 0.39) than the control group (OR 0.471; 95% CI, -2.40, 3.34). The CCRI reported positive evaluations for the intervention (e.g., ease of use, helpfulness, perceived stress reduction)., Conclusion(s): Use of the CCRI tool led to improved psychological status but not statistically significantly more treatment cycles or a higher pregnancy rate., Clinical Trial Registration Number: NCT01318291., (Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

This review argues that optimal in vitro fertilization in 2020 should include a way of enhancing the delivery of treatment for patients and staff by the minimization of patient, treatment, and clinic sources of burden. Two specific sources of burden are addressed. First, patient vulnerability can be tackled by implementation of pretreatment evidence-based screening for psychological distress, appropriate referral for support, elimination of barriers to acceptance of psychosocial support, and implementation of a routine care flowchart that identifies the specific stages of treatment when psychosocial support should be provided. Second, negative patient-staff interactions can be avoided by training staff in communication/interaction skills, promoting shared decision making, prioritizing psychological interventions that address aspects of care equally problematic for patients and staff, and monitoring the impact of change on patient, staff, and clinic outcomes. In addition, optimal in vitro fertilization should ensure now that the future generations of young adults know what "achieving parenthood" actually entails in the context of the many desired goals of adulthood, greater variety of reproductive techniques available, later age of first births, and, consequently, longer exposure to risk factors (e.g., smoking) that affect fertility., (Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in females, with a high prevalence. The etiology of this heterogeneous condition remains obscure, and its phenotype expression varies. Two widely cited previous ESHRE/ASRM sponsored PCOS consensus workshops focused on diagnosis (published in 2004) and infertility management (published in 2008), respectively. The present third PCOS consensus report summarizes current knowledge and identifies knowledge gaps regarding various women's health aspects of PCOS. Relevant topics addressed-all dealt with in a systematic fashion-include adolescence, hirsutism and acne, contraception, menstrual cycle abnormalities, quality of life, ethnicity, pregnancy complications, long-term metabolic and cardiovascular health, and finally cancer risk. Additional, comprehensive background information is provided separately in an extended online publication., (Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate whether older first-time mothers (≥37 years) have higher rates of postpartum depression compared with younger first-time mothers, controlling for mode of conception and known risk factors for postpartum depression., Design: Prospective cohort study., Setting: Assisted reproductive technology (ART) clinics in two large Australian cities and public and private antenatal clinics and/or classes in the vicinity of ART clinics., Patient(s): Nulliparous women who had conceived spontaneously (n = 295) or through ART (n = 297) in three age-groups: younger, 20 to 30 years (n = 173); middle, 31 to 36 years (n = 214); and older, ≥37 years (n = 189)., Intervention(s): Semistructured interviews and questionnaires., Main Outcome Measure(s): Major depressive disorder in the first 4 months after birth as assessed by structured diagnostic interview., Result(s): The study performed 592 complete pregnancy assessments and 541 postpartum assessments. The prevalence of major depressive disorder was 7.9%, at the lower end of community rates. Neither maternal age-group nor mode of conception was statistically significantly related to depression., Conclusion(s): Older first-time mothers, whether conceiving through ART or spontaneously, do not show increased vulnerability to postnatal depression., (Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To develop the first international instrument to measure fertility quality of life, FertiQoL, in men and women experiencing fertility problems, to evaluate the preliminary psychometric properties of this new tool and to translate FertiQoL into multiple languages., Design: Survey., Setting: Online and fertility clinics in USA, Australia/New Zealand, Canada, and United Kingdom., Participants: A total of 1,414 people with fertility problems., Intervention(s): None., Main Outcome Measure(s): FertiQoL., Result(s): FertiQoL consists of 36 items that assess core (24 items) and treatment-related (10 items) quality of life as well as overall life and physical health (2 items). Cronbach reliability statistics for the Core and Treatment FertiQoL (and subscales) were satisfactory, in the range of 0.72 and 0.92. Sensitivity analyses showed that FertiQoL detected expected relations between quality of life and gender, parity, and support seeking. FertiQoL was translated into 20 languages by the same translation team, with each translation verified by local bilingual fertility experts., Conclusion(s): FertiQoL is a reliable measure of the impact of fertility problems and its treatment on quality of life. Future research should establish its use in cross-cultural research and clinical work., (Copyright © 2011. Published by Elsevier Inc.)

Objective: To examine the separate and joint effects of male and female fertility problem (FP) stress and the source of stress (e.g., personal, social, marital) on treatment outcome., Design: Prospective, epidemiological cohort design., Setting: Fertility clinics in Denmark., Patient(s): Eight hundred eighteen couples who were about to begin a new course of treatment., Intervention(s): An FP stress inventory was administered at the start of treatment, and the treatment outcome was evaluated 12 months later., Main Outcome Measure(s): Number of treatment cycles in 12-month study period and treatment outcome (i.e., success, no success)., Result(s): Fertility problem stress was associated with a poorer treatment outcome in women (pooled within-groups [WGr] correlation,WGr = .517) and men (WGr = .392) with the effect significantly more pronounced for women (z = 3.19, P<.001). Fertility problem stress arising in the personal and marital domain showed greater associations with treatment outcome than did FP stress from the social domain. Logistic regression indicated that women who reported more marital distress required more treatment cycles to conceive (median 3) than women reporting less marital distress (median 2) (odds ratio [OR] = 1.20: Model chi2(3) = 77.21, P<.001)., Conclusion(s): The findings provide evidence that infertility-related stress has direct and indirect effects on treatment outcome.

Objective: To examine the relationship between stress and IVF outcome in women and to compare prospective ratings of IVF stress to retrospective ratings., Design: Women completed daily stress ratings for one complete IVF cycle. Three days after the pregnancy test women completed a questionnaire that asked them to recall the stress of IVF. Based on the results of treatment, women were assigned to the nonpregnant (n = 23) or pregnant (n = 17) group and their daily stress ratings were compared. In addition, prospective and retrospective ratings were compared., Results: The nonpregnant group reported more stress during specific stages of IVF and had a poorer biologic response to treatment than the pregnant group. It also was found that women recalled the stress of the waiting period as greater than their ongoing experience of it as measured by their daily ratings., Conclusions: The pattern of differences between the nonpregnant and pregnant group on stress and biologic factors indicates that stress is related to IVF outcome. Certain data suggest that negative feedback about the progress of treatment communicated to patients responding poorly to IVF (nonpregnant group) may have increased their stress level. However, the direction of causality between stress and IVF outcome remains speculative. Differences between prospective and retrospective stress ratings may reflect women's attempt to cope with the strain of the waiting period.

Objective: To examine the relationship between amount of treatment failure and personal and marital distress., Design: In this cross-sectional design, three groups of women (n = 91) with varying amounts of treatment failure experience were compared on measures of general and infertility-related distress and marital and sexual distress., Results: The relationship between treatment failure experience and personal and marital distress was found to be curvilinear. The group that had a moderate amount of treatment failure experienced the most distress whereas the distress level of those without or with a high amount of treatment failure experience was comparable. The results also showed that the relationship between amount of treatment failure and distress was independent of age, years infertile, or years in treatment., Conclusion: The findings of this study provide support for infertility theories that suggest that infertility is a process rather than a series of independent emotional events and suggest that the distress women experience during infertility is a necessary part of their evolution toward acceptance of their infertility.