National Institute for Health and Care Excellence, 2026·National Institute for Health and Care Excellence
Second draft guidance (consultation 15 September to 5 October 2026; expected publication 21 January 2027). Recommendation 1.1: Endotest (Ziwig, saliva 109-microRNA signature, CE IVDR class C, ages 18 to 43, GBP 1,381 per test) can be used in the NHS during a 4-year evidence generation period as an option to diagnose endometriosis in primary care, only when clinical examination is normal and ultrasound is negative, inconclusive, declined or not suitable. Recommendation 1.5: more research is needed on DotEndo (DotLab blood microRNA, GBP 400), Endomkit (Camlab/apDia serum BDNF plus CA-125, GBP 28 to 199) and EndoSure (gastrointestinal myoelectrical activity, GBP 350) before NHS funding. Committee noted all peer-reviewed accuracy evidence came from secondary or tertiary care where prevalence is higher than in primary care; the developmental Endotest cohort was judged at high risk of bias and the external validation studies at unclear risk; DotEndo, Endomkit and EndoSure had no external validation studies; no study reported clinical outcomes; the technologies cannot distinguish types of endometriosis or determine severity; clinical experts stated a negative result should not be a reason to deny referral if endometriosis is still suspected; imaging does not identify all types, particularly superficial peritoneal endometriosis. Average time to diagnosis in the UK cited as 9 years 4 months.
Diagnostic Criteria and Classification · Terminology and Definitions
Minjeur M et al., 2026·Journal of Restorative Reproductive Medicine·Free to read
Infertility is a clinical condition that is recognized by the symptom of an inability to conceive through sexual intercourse or to sustain a pregnancy, with that symptom indicating underlying male and/or female pathology.
This definition of infertility was developed through a structured, consensus-informed process involving broad stakeholder engagement. Initially, multiple definitions currently used by various medical professional organizations were reviewed, and a definition document was drafted and submitted to the Board of Directors of the International Institute for Restorative Reproductive Medicine (IIRRM). All IIRRM members were invited to provide feedback on the draft. Approximately 2,500 individuals and 44 organizations from 92 countries were then invited to review the proposed document, representing clinical, scientific, patient, policy, and advocacy perspectives. Submitted comments were reviewed thematically, with suggested revisions evaluated for clarity, clinical relevance, inclusiveness, and consistency with contemporary restorative reproductive medicine. Following this review, 3 substantive changes, 18 minor changes, and 15 citation corrections were incorporated into the final draft which resulted in a revised definition intended to better reflect the medical, social, and practical realities of modern infertility evaluation and care. Final approval by the IIRRM Board of Directors was unanimous.
Diagnostic Criteria and Classification · Terminology and Definitions
Teede HJ et al., 2026·Lancet (London, England)·Free to read
Polyendocrine metabolic ovarian syndrome (PMOS), previously named polycystic ovary syndrome (PCOS), affects one in eight women. However, the term PCOS is inaccurate, implying pathological ovarian cysts, obscuring diverse endocrine and metabolic features, and contributing to delayed diagnosis, fragmented care, and stigma, while curtailing research and policy framing. Building on an international mandate for change, we outline an unprecedented, rigorous, multistep global consensus process for the name change. Funding and governance were established with engagement of 56 leading academic, clinical, and patient organisations. Using iterative global surveys (with responses from 14 360 people with PCOS and multidisciplinary health professionals from all world regions), modified Delphi methods, nominal group technique workshops, and marketing and implementation analyses, we identified principles prioritising scientific accuracy, clarity, stigma avoidance, cultural appropriateness, and implementation feasibility. An accurate new name was prioritised over retaining the PCOS acronym or a generic name. Implementation approaches prioritised evolution rather than transformation. Preferred terms were polyendocrine, metabolic, and ovarian, reflecting the condition's multisystem pathophysiology, and polyendocrine metabolic ovarian syndrome was the consensus new name. Accuracy was improved by omitting cysts and by capturing endocrine, metabolic, and ovarian dysfunction. A co-designed global implementation strategy, including a transition period, education, and alignment with health systems and disease classification, is under way.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine, 2026·Fertility and Sterility
Current strategies for the assessment and treatment of recurrent pregnancy loss are discussed. This replaces the previous document, titled, "Evaluation and treatment of recurrent pregnancy loss: a committee opinion," last published in 2012.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine, 2025·Fertility and sterility
It has been estimated that only a quarter of persons with infertility in the United States can sufficiently access infertility care. Against this backdrop of disparity, specific populations, including persons of color, sexual and gender minorities, immigrants, and lower-income persons, face barriers that further constrain access to care. This document outlines these communities' barriers and reviews best practice recommendations to extend inclusive access to care for marginalized populations. This reference is intended to support health professionals with knowledge of barriers that limit access to care and to provide practical strategies to improve access and optimize healthcare delivery.
Guidelines by Issuing Body · Specialty and Consensus Panels
Kim NN et al., 2025·Sexual medicine reviews·Free to read
Sexual function is a critical issue for human health and impacts the quality of life of patients and their partners. In this ICSM report, basic science and translational perspectives have been examined from the past decade of literature since the last ICSM report, and have been integrated to produce a state of the art summary of the physiology and molecular biology of sexual function/dysfunction and development of novel nanotechnology-based vehicles and treatments to aid regeneration and clinical translation in men and women.
Examine, critically assess, and curate the most important and impactful basic and translational research findings on male and female sexual dysfunction since 2015.
Literature reviews were performed by a multidisciplinary committee of sexual medicine experts between June 2023 through May 2024. Findings were presented at the ICSM meeting in Madrid (June 2024), and comments from the consultation were incorporated to develop this consensus report.
Erectile dysfunction (ED), which accompanies prostatectomy, diabetes, aging, and vascular disease in men, develops through both common and distinct mechanisms that involve neural injury, penile remodeling (smooth muscle (SM) apoptosis and increased collagen/fibrosis), dysregulated SM contractility, increased oxidative stress, immune response, and genomic instability. In women, disorders of genital pain, arousal, sexual desire, and orgasm involve multiple, overlapping neurological and endocrine mechanisms. Research on ED has been more extensive and the underlying molecular mechanisms have been better characterized than female sexual dysfunction. Future research directions should focus on pathways that underlie penile tissue remodeling and fibrosis associated with cavernous nerve injury in prostatectomy and diabetes, since this leads to irreversible ED. Particular emphasis should be placed on therapeutic targets to improve/enhance nerve regeneration, neuroprotection, "on demand" sexual function, SM contractility/relaxation, oxidative stress, immune response, and hormone function. In women, despite the existence of approved and off-label treatments for disorders of sexual desire and orgasm, the greater influence of psychosocial factors for these aspects of sexual function demands a multidisciplinary approach, along with predictive animal models. Genome-wide association studies have great potential in advancing the field but require replication and functional validation of findings from bioinformatic analyses. Progress in nanotechnology and regenerative therapies offers an exciting frontier in the targeted delivery of ameliorative/restorative treatments.
Research in sexual medicine has expanded through accelerated rates of discovery and increased breadth and diversity. However, much work remains in translating preclinical findings into biomarkers and clinical therapies that can improve patient outcomes.
Guidelines by Clinical Area · Bone and Endocrine Guidelines
Zitzmann M et al., 2025·The aging male : the official journal of the International Society for the Study of the Aging Male·Free to read
This is the inaugural recommendation for the management of the Aging Male with Klinefelter Syndrome (KS), a demographic characterized by primary hypogonadism in the presence of one or more supernumerary X-chromosomes with irregular gene-inactivation, and metabolic dysregulation, contributing a component of functional hypogonadism as aging in these men progresses. The unique constellation of symptoms spanning multiple organ systems and health domains necessitates specialized diagnostic and therapeutic strategies. Neglecting the specific needs of this population can precipitate a considerable decline in quality of life and overall health outcomes. Our recommendations advocate for a multidisciplinary approach involving endocrinologists, urologists, geneticists, mental health professionals, and other specialists, to address the complex interplay of hormonal imbalances, metabolic disorders, cardiovascular risk factors including arrhythmia, bone health concerns, psychological and sexual challenges, ophthalmological problems, and dental issues. By providing a structured framework for comprehensive and individualized care, these recommendations aim to bridge existing healthcare gaps, optimize well-being, and enhance the overall quality of life for aging men with KS.
Guidelines by Clinical Area · Obstetric Guidelines
Davenport MH et al., 2025·British journal of sports medicine
This consensus aims to provide guidance for postpartum women and people, healthcare providers and exercise professionals on physical activity, sedentary behaviour and sleep throughout the first year postpartum. The development of this guideline followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology and the Appraisal of Guidelines for Research and Evaluation II instrument. The Guideline Consensus Panel consisted of representatives from key professional groups, researchers and methodological experts. Literature was retrieved through searches of 12 online databases, and articles on maternal physical activity, sedentary behaviour or sleep in the first year after childbirth were eligible for inclusion if they reported on any of 21 maternal or infant health outcomes, which were prioritised considering the preferences and values of postpartum individuals. There was no restriction on language, and all study designs were eligible except for case studies. The certainty of evidence was rated using GRADE. This evidence review produced seven systematic reviews, which informed this consensus statement. A Delphi process was conducted to identify relative contraindications to postpartum moderate-intensity to vigorous-intensity physical activity, which informed the development of the Get Active Questionnaire for Postpartum. Evidence to decision tables were developed, and feedback on the recommendations was solicited from end users (healthcare providers, exercise professionals, researchers, policy organisations and postpartum women and people). Adhering to these consensus recommendations for postpartum women and people is likely to result in large improvements in psychological well-being, as well as pelvic, musculoskeletal and cardiometabolic health, and reduced fatigue, while not experiencing adverse events (moderate certainty evidence). Most end users indicated that following these recommendations would be feasible, acceptable and equitable, and likely to require minimal resources from individual and health systems perspectives. PROSPERO registration number CRD42022359282.
Diagnostic Criteria and Classification · Diagnostic Criteria
Facchinetti F et al., 2025·Journal of endocrinological investigation
To gather the current opinion among Italian gynecologists and endocrinologists regarding the definition, diagnosis, and treatment of polycystic ovary syndrome (PCOS).
A Delphi survey consisting of 26 statements was designed by a nine-member panel (consisting of members from the Italian Society of Endocrinology (SIE) and the Experts Group AQon Inositol in Basic and Clinical Research and on PCOS (EGOI-PCOS)) and distributed to 102 experts in PCOS across the fields of gynecology and endocrinology. Consensus was defined as an agreement between at least 70% of responders. Participants completed three rounds of statements, ranking their level of agreement.
Of the initial 26 statements, 25 reached an adequate consensus, with an overall response rate of 73%. The statements were divided into three sections: definition and current understanding, diagnosis, and treatment. Of the statements that reached consensus, near total agreement was reached in the first two sections, whereas there was a divergence of opinion in terms of optimum treatment strategy between the gynecology and endocrinology subgroups.
It was agreed that the current clinical guidelines are inadequate for clinical and scientific practice, with most responders advocating for the inclusion of metabolic factors. Furthermore, the consensus opinion advocated for the diversification of hyperandrogenic vs. non-hyperandrogenic phenotypes. This survey gives a snapshot of the current understanding of PCOS in the Italian healthcare community.
Guidelines by Clinical Area · Bone and Endocrine Guidelines
How should premature/primary ovarian insufficiency (POI) be diagnosed and managed, based on the best available evidence from published literature? The current guideline provides 145 recommendations on symptoms, diagnosis, causation, sequelae and treatment of POI. POI presents a significant challenge to women's health, with far-reaching implications, both physically and emotionally. The potential implications include adverse effects on quality of life, on fertility and on bone, cardiovascular and cognitive health. Although hormone therapy (HT) can mitigate some of these effects, many questions still remain regarding the optimal management of POI. STUDY DESIGN, SIZE, The guideline was developed according to the structured methodology for development of European Society of Human Reproduction and Embryology (ESHRE) guidelines. Key questions were determined by a group of experts and informed by a scoping survey of women and healthcare professionals. Literature searches and assessment were then performed. Papers published up to 30 January 2024 and written in English were included in the guideline. An integrity review was conducted for the randomized controlled trials on POI included in the guideline. PARTICIPANTS/MATERIALS, SETTING, Based on the collected evidence, recommendations were formulated and discussed within the guideline development group until consensus was reached. Women with lived experience of POI informed the recommendations in general, and particularly those on provision of care. A stakeholder review was organized after finalization of the draft. The final version was approved by the guideline development group and the ESHRE Executive Committee. MAIN New data indicate a higher prevalence of POI, 3.5%, than was previously thought. This guideline aims to help healthcare professionals apply best practice care for women with POI. The recent update of the POI guideline covers 40 clinical questions on diagnosis of the condition, the different sequelae, including bone, cardiovascular, neurological and sexual function, fertility and general well-being, and treatment options, including HT. The list of clinical questions was expanded from the previous iteration of the guideline (2015) based on the scoping survey and appreciation of emerging knowledge of POI. Questions were added on the role of anti-Müllerian hormone (AMH) in the diagnosis of POI, fertility preservation, muscle health and specific considerations for HT in iatrogenic POI. Additionally, the topic on complementary treatments was extended with specific focus on non-hormonal treatments and lifestyle management options. Significant changes from the previous 2015 guideline include the recommendations that only one elevated follicle stimulating hormone (FSH) >25 IU is required for diagnosis of POI and guidance that AMH testing, repeat FSH measurement and/or AMH may be required where there is diagnostic uncertainty. Recommendations were also updated regarding genetic testing, estrogen doses and regimens, use of the combined oral contraceptive and testosterone therapy. Women with lived experience of POI informed the recommendations on provision of care. LIMITATIONS, The guideline describes different management options, but it must be acknowledged that for most of these options, supporting evidence is limited for POI. The guideline provides healthcare professionals with clear advice on best practice in POI care, based on the best evidence currently available. In addition, a list of research recommendations is provided to guide further studies in POI.
Guidelines by Issuing Body · Specialty and Consensus Panels
Reproductive Technology Accreditation Committee et al., 2024·Fertility Society of Australia and New Zealand - RTAC
RTAC Code of Practice (Issue 9) governing accreditation requirements for reproductive technology units operating in Australia and New Zealand. Sets standards for clinical, laboratory, and quality-management practices that ART centres must meet to remain RTAC-accredited and eligible to submit cycles to ANZARD. Includes patient safety, embryology laboratory, donor-program, and incident-reporting requirements. Effective from December 2024.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology, 2024·Fertil Steril
The use of preimplantation genetic testing for aneuploidy (PGT-A) in the United States has been increasing steadily. Moreover, the underlying technology used for 24-chromosome analysis continues to evolve rapidly. The value of PGT-A as a routine screening test for all patients undergoing in vitro fertilization has not been demonstrated. Although some earlier single-center studies reported higher live-birth rates after PGT-A in favorable-prognosis patients, recent multicenter, randomized control trials in women with available blastocysts concluded that the overall pregnancy outcomes via frozen embryo transfer were similar between PGT-A and conventional in vitro fertilization. The value of PGT-A to lower the risk of clinical miscarriage is also unclear, although these studies have important limitations. This document replaces the document of the same name, last published in 2018.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine, 2024·Fertility and Sterility
In the United States, approximately 21% of adults report some form of tobacco use, although 18% report marijuana use. Although the negative impact of tobacco use in pregnancy is well documented, the impact of tobacco and marijuana on fertility and reproduction is less clear. This committee opinion reviews the potential deleterious effects of tobacco, nicotine, and marijuana use on conception, ovarian follicular dynamics, sperm parameters, gamete mutations, early pregnancy, and assisted reproductive technology outcomes. It also reviews the current status of tobacco smoking cessation strategies. This document replaces the 2018 American Society for Reproductive Medicine Practice Committee document entitled Smoking and Infertility: a committee opinion (Fertil Steril 2018).
Guidelines by Clinical Area · Gynecologic Guidelines
Singh SS et al., 2024·Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC
To provide a contemporary approach to the understanding of the impact and methods for the diagnosis of endometriosis in Canada.
Individuals, families, communities, health care providers, and health care administrators who are affected by, care for patients with, or manage delivery of services for endometriosis.
The diagnosis of endometriosis is facilitated by a detailed history, examination, and imaging tests with providers who are experienced in endometriosis care. Surgical evaluation with pathology confirms a diagnosis of endometriosis; however, it is not required for those whose diagnosis was confirmed with imaging.
There is a need to address earlier recognition of endometriosis to facilitate timely access to care and support. Education directed at the public, affected individuals and families, health care providers, and health care administrators are essential to reduce delays in diagnosis and treatment.
BENEFITS, HARMS, Increased awareness and education about the impact and approach to diagnosis may support timely access to care for patients and families affected by endometriosis. Earlier and appropriate care may support a reduced health care system burden; however, improved clinical evaluation may require initial investments.
Each section was reviewed with a unique search strategy representative of the evidence available in the literature related to the area of focus. The literature searches for each section of this guideline are listed in Appendix A and include information from published systematic reviews described in the text.
The recommendations were developed following two rounds of review by a national expert panel through an iterative 2-year consensus process. Further details on the process are shared in Appendix B. The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See Appendix C (Table C1 for definitions and Table C2 for interpretations of strong and conditional recommendations).
This guideline is intended to support health care providers and policymakers involved in the care of those impacted by endometriosis and the systems required to support them.
Endometriosis impact and diagnosis updated guidelines for Canadian health care providers and policymakers.
RECOMMENDATIONS.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine, 2024·Fertility and Sterility
Ovarian hyperstimulation syndrome is a serious complication associated with assisted reproductive technology. This systematic review aims to identify who is at high risk for developing ovarian hyperstimulation syndrome, along with evidence-based strategies to prevent it and replaces the document of the same name last published in 2016.
Guidelines by Issuing Body · Specialty and Consensus Panels
Farlie F et al., 2024·Reproductive biomedicine online·Free to read
The healthcare industry is a major contributor to greenhouse gas emissions. Assisted reproductive technology is part of the larger healthcare sector, with its own heavy carbon footprint. The social, economic and environmental costs of this collective carbon footprint are becoming clearer, as is the impact on human reproductive health. Alpha Scientists in Reproductive Medicine and the International IVF Initiative collaborated to seek and formulate practical recommendations for sustainability in IVF laboratories. An international panel of experts, enthusiasts and professionals in reproductive medicine, environmental science, architecture, biorepository and law convened to discuss the topics of importance to sustainability. Recommendations were issued on how to build a culture of sustainability in the workplace, implement green design and building, use life cycle analysis to determine the environmental impact, manage cryostorage more sustainably, and understand and manage laboratory waste with prevention as a primary goal. The panel explored whether the industry supporting IVF is sustainable. An example is provided to illustrate the application of green principles to an IVF laboratory through a certification programme. The UK legislative landscape surrounding sustainability is also discussed and a few recommendations on 'Green Conferencing' are offered.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org, 2023·Fertility and sterility
Sexually transmitted infections are of major concern to reproductive specialists. Heading the list are human immunodeficiency virus types 1 and 2 and hepatitis B and C viruses. These pathogens, which may cause incurable chronic infections, can be transmitted through assisted reproductive technologies and from infected mothers to the fetus or newborn. This document replaces the document of the same name, last published in 2020.
Diagnostic Criteria and Classification · Staging and Classification Systems
Jain V et al., 2023·International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics·Free full text on PubMed Central
Abnormal uterine bleeding (AUB) is common, often debilitating, and may affect over 50% of reproductive-aged women and girls. Whereas AUB is a collection of symptoms that include intermenstrual bleeding and abnormalities in period duration, cycle length, and regularity, it is heavy menstrual bleeding (HMB) that is most contributory to iron deficiency and related anemia. It is apparent that AUB, in general, and HMB, in particular, remain underrecognized and underreported. FIGO created two systems for assessing and classifying AUB. FIGO System 1 defines the bleeding pattern using four primary descriptors: frequency, duration, regularity, and flow volume. FIGO System 2 provides a structured classification system of possible causes of AUB, using the acronym PALM-COEIN. "PALM" refers to structural causes of AUB (Polyp, Adenomyosis, Leiomyoma, Malignancy), and "COEI" refers to nonstructural causes (Coagulopathy, Ovulatory dysfunction, Endometrial, and Iatrogenic). The "N" is reserved for those entities that are currently not otherwise classified. Using FIGO System 1 as a gateway to FIGO System 2 streamlines the investigation of reproductive-aged women and girls with AUB. Understanding the pathogenesis of the FIGO System 2 "PALM-COEIN" causes helps interpret investigations and the onward management of AUB. Numerous evidence gaps exist concerning AUB; however, if researchers and trialists universally adopt FIGO Systems 1 and 2 for the assessment and diagnosis of AUB, clear translatable research findings can be applied globally.
Guidelines by Clinical Area · Bone and Endocrine Guidelines
Corona G et al., 2023·Journal of endocrinological investigation·Free full text on PubMed Central
Erectile dysfunction (ED) is one of the most prevalent male sexual dysfunctions. ED has been in the past mistakenly considered a purely psycho-sexological symptom by patients and doctors. However, an ever-growing body of evidence supporting the role of several organic factors in the pathophysiological mechanisms underlying ED has been recognized.
The Italian Society of Andrology and Sexual Medicine (SIAMS) commissioned an expert task force involving several other National Societies to provide an updated guideline on the diagnosis and management of ED. Derived recommendations were based on the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.
Several evidence-based statements were released providing the necessary up-to-date guidance in the context of ED with organic and psychosexual comorbidities. Many of them were related to incorrect lifestyle habits suggesting how to associate pharmacotherapies and counseling, in a couple-centered approach. Having the oral therapy with phosphodiesterase type 5 inhibitors as the gold standard along with several other medical and surgical therapies, new therapeutic or controversial options were also discussed.
These are the first guidelines based on a multidisciplinary approach that involves the most important Societies related to the field of sexual medicine. This fruitful discussion allowed for a general agreement on several recommendations and suggestions to be reached, which can support all stakeholders in improving couple sexual satisfaction and overall general health.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Cimadomo D et al., 2023·Human Reproduction Open·Free full text on PubMed Central
Abstract How should recurrent implantation failure (RIF) in patients undergoing ART be defined and managed? This is the first ESHRE good practice recommendations paper providing a definition for RIF together with recommendations on how to investigate causes and contributing factors, and how to improve the chances of a pregnancy. RIF is a challenge in the ART clinic, with a multitude of investigations and interventions offered and applied in clinical practice, often without biological rationale or with unequivocal evidence of benefit. STUDY DESIGN, SIZE, This document was developed according to a predefined methodology for ESHRE good practice recommendations. Recommendations are supported by data from the literature, if available, and the results of a previously published survey on clinical practice in RIF and the expertise of the working group. A literature search was performed in PubMed and Cochrane focussing on ‘recurrent reproductive failure’, ‘recurrent implantation failure’, and ‘repeated implantation failure’. PARTICIPANTS/MATERIALS, SETTING, The ESHRE Working Group on Recurrent Implantation Failure included eight members representing the ESHRE Special Interest Groups for Implantation and Early Pregnancy, Reproductive Endocrinology, and Embryology, with an independent chair and an expert in statistics. The recommendations for clinical practice were formulated based on the expert opinion of the working group, while taking into consideration the published data and results of the survey on uptake in clinical practice. The draft document was then open to ESHRE members for online peer review and was revised in light of the comments received. MAIN The working group recommends considering RIF as a secondary phenomenon of ART, as it can only be observed in patients undergoing IVF, and that the following description of RIF be adopted: ‘RIF describes the scenario in which the transfer of embryos considered to be viable has failed to result in a positive pregnancy test sufficiently often in a specific patient to warrant consideration of further investigations and/or interventions'. It was agreed that the recommended threshold for the cumulative predicted chance of implantation to identify RIF for the purposes of initiating further investigation is 60%. When a couple have not had a successful implantation by a certain number of embryo transfers and the cumulative predicted chance of implantation associated with that number is greater than 60%, then they should be counselled on further investigation and/or treatment options. This term defines clinical RIF for which further actions should be considered. Nineteen recommendations were formulated on investigations when RIF is suspected, and 13 on interventions. Recommendations were colour-coded based on whether the investigations/interventions were recommended (green), to be considered (orange), or not recommended, i.e. not to be offered routinely (red). LIMITATIONS, While awaiting the results of further studies and trials, the ESHRE Working Group on Recurrent Implantation Failure recommends identifying RIF based on the chance of successful implantation for the individual patient or couple and to restrict investigations and treatments to those supported by a clear rationale and data indicating their likely benefit. This article provides not only good practice advice but also highlights the investigations and interventions that need further research. This research, when well-conducted, will be key to making progress in the clinical management of RIF. STUDY FUNDING/COMPETING INTEREST(S)
The meetings and technical support for this project were funded by ESHRE. N.M. declared consulting fees from ArtPRED (The Netherlands) and Freya Biosciences (Denmark); Honoraria for lectures from Gedeon Richter, Merck, Abbott, and IBSA; being co-founder of Verso Biosense. He is Co-Chief Editor of Reproductive Biomedicine Online (RBMO). D.C. declared being an Associate Editor of Human Reproduction Update, and declared honoraria for lectures from Merck, Organon, IBSA, and Fairtility; support for attending meetings from Cooper Surgical, Fujifilm Irvine Scientific. G.G. declared that he or his institution received financial or non-financial support for re
Diagnostic Criteria and Classification · Staging and Classification Systems
Munro MG et al., 2022·Human Reproduction·Free full text on PubMed Central
Ovulatory disorders are common causes of amenorrhea, abnormal uterine bleeding and infertility and are frequent manifestations of polycystic ovary syndrome (PCOS). There are many potential causes and contributors to ovulatory dysfunction that challenge clinicians, trainees, educators, and those who perform basic, translational, clinical and epidemiological research. Similarly, therapeutic approaches to ovulatory dysfunction potentially involve a spectrum of lifestyle, psychological, medical and procedural interventions. Collaborative research, effective education and consistent clinical care remain challenged by the absence of a consensus comprehensive system for classification of these disorders. The existing and complex system, attributed to the World Health Organization (WHO), was developed more than three decades ago and did not consider more than 30 years of research into these disorders in addition to technical advances in imaging and endocrinology. This article describes the development of a new classification of ovulatory disorders performed under the aegis of the International Federation of Gynecology and Obstetrics (FIGO) and conducted using a rigorously applied Delphi process. The stakeholder organizations and individuals who participated in this process comprised specialty journals, experts at large, national, specialty obstetrical and gynecological societies, and informed lay representatives. After two face-to-face meetings and five Delphi rounds, the result is a three-level multi-tiered system. The system is applied after a preliminary assessment identifies the presence of an ovulatory disorder. The primary level of the system is based on an anatomic model (Hypothalamus, Pituitary, Ovary) that is completed with a separate category for PCOS. This core component of the system is easily remembered using the acronym HyPO-P. Each anatomic category is stratified in the second layer of the system to provide granularity for investigators, clinicians and trainees using the GAIN-FIT-PIE mnemonic (Genetic, Autoimmune, Iatrogenic, Neoplasm; Functional, Infectious and Inflammatory, Trauma and Vascular; Physiological, Idiopathic, Endocrine). The tertiary level allows for specific diagnostic entities. It is anticipated that, if widely adopted, this system will facilitate education, clinical care and the design and interpretation of research in a fashion that better informs progress in this field. Integral to the deployment of this system is a periodic process of reevaluation and appropriate revision, reflecting an improved understanding of this collection of disorders.
Guidelines by Clinical Area · Bone and Endocrine Guidelines
Isidori AM et al., 2022·Journal of endocrinological investigation·Free full text on PubMed Central
To provide the evidence-based recommendations on the role of testosterone (T) on age-related symptoms and signs remains.
The Italian Society of Andrology and Sexual Medicine (SIAMS) and the and the Italian Society of Endocrinology (SIE) commissioned an expert task force to provide an updated guideline on adult-onset male hypogonadism. Derived recommendations were based on Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.
Clinical diagnosis of adult-onset hypogonadism should be based on a combination of clinical and biochemical parameters. Testosterone replacement therapy (TRT) should be offered to all symptomatic subjects with hypogonadism after the exclusion of possible contraindications. T gels and the long-acting injectable T are currently available preparations showing the best efficacy/safety profile. TRT can improve all aspects of sexual function, although its effect is limited in more complicated patients. Body composition (reducing fat mass and increasing lean mass) is improved after TRT, either in subjects with or without metabolic syndrome or type 2 diabetes. Conversely, the role of TRT in improving glycometabolic control is more conflicting. TRT can result in increasing bone mineral density, particularly at lumbar site, but no information on fracture risk is available. Limited data support the use of TRT for improving other outcomes, including mood frailty and mobility.
TRT can improve sexual function and body composition particularly in less complicated adult and in aging subjects with hypogonadism. When hypogonadism is adequately diagnosed, T appropriately prescribed and subjects correctly followed up, no short-term increased risk of adverse events is observed. Longer and larger studies are advisable to better clarify TRT long-term efficacy/safety profile.
Guidelines by Clinical Area · Obstetric Guidelines
Adams JB et al., 2022·Maternal health, neonatology and perinatology·Free full text on PubMed Central
The blood levels of most vitamins decrease during pregnancy if un-supplemented, including vitamins A, C, D, K, B1, B3, B5, B6, folate, biotin, and B12. Sub-optimal intake of vitamins from preconception through pregnancy increases the risk of many pregnancy complications and infant health problems. In the U.S., dietary intake of vitamins is often below recommended intakes, especially for vitamin D, choline and DHA. Many studies suggest that insufficient vitamin intake is associated with a wide range of pregnancy complications (anemia, Cesarean section, depression, gestational diabetes, hypertension, infertility, preeclampsia, and premature rupture of membranes) and infant health problems (asthma/wheeze, autism, low birth weight, congenital heart defects, intellectual development, intrauterine growth restriction, miscarriage, neural tube defects, orofacial defects, and preterm birth). The primary goal of this paper is to review the research literature and propose evidence-based recommendations for the optimal level of prenatal supplementation for each vitamin for most women in the United States. A secondary goal was to compare these new recommendations with the levels of vitamins in over 180 commercial prenatal supplements. The analysis found that prenatal supplements vary widely in content, often contained only a subset of essential vitamins, and the levels were often below our recommendations. This suggests that increasing prenatal vitamin supplementation to the levels recommended here may reduce the incidence of many pregnancy complications and infant health problems which currently occur.
Guidelines by Clinical Area · Bone and Endocrine Guidelines
“The 2022 Hormone Therapy Position Statement of The North American Menopause Society” Advisory Panel, 2022·Menopause (New York, N.Y.)
"The 2022 Hormone Therapy Position Statement of The North American Menopause Society" (NAMS) updates "The 2017 Hormone Therapy Position Statement of The North American Menopause Society" and identifies future research needs. An Advisory Panel of clinicians and researchers expert in the field of women's health and menopause was recruited by NAMS to review the 2017 Position Statement, evaluate new literature, assess the evidence, and reach consensus on recommendations, using the level of evidence to identify the strength of recommendations and the quality of the evidence. The Advisory Panel's recommendations were reviewed and approved by the NAMS Board of Trustees.Hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture. The risks of hormone therapy differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used. Treatment should be individualized using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation of the benefits and risks of continuing therapy.For women aged younger than 60 years or who are within 10 years of menopause onset and have no contraindications, the benefit-risk ratio is favorable for treatment of bothersome VMS and prevention of bone loss. For women who initiate hormone therapy more than 10 years from menopause onset or who are aged older than 60 years, the benefit-risk ratio appears less favorable because of the greater absolute risks of coronary heart disease, stroke, venous thromboembolism, and dementia. Longer durations of therapy should be for documented indications such as persistent VMS, with shared decision-making and periodic reevaluation. For bothersome genitourinary syndrome of menopause symptoms not relieved with over-the-counter therapies in women without indications for use of systemic hormone therapy, low-dose vaginal estrogen therapy or other therapies (eg, vaginal dehydroepiandrosterone or oral ospemifene) are recommended.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committees of the American Society for Reproductive Medicine (ASRM) and the Society for Reproductive Biologists and Technologists (SRBT). Electronic address: asrm@asrm.org, 2022·Fertility and sterility
This document is a comprehensive guidance for human embryology, andrology, and endocrinology laboratories. Universal guidance applicable to all laboratories includes requirements and recommendations for accreditation and staffing in the United States, and specific guidance is included for each laboratory specialty.
Guidelines by Clinical Area · Obstetric Guidelines
Society for Maternal-Fetal Medicine et al., 2022·American Journal of Obstetrics and Gynecology·Free full text on PubMed Central
The use of assisted reproductive technology has increased in the United States in the past several decades. Although most of these pregnancies are uncomplicated, in vitro fertilization is associated with an increased risk for adverse perinatal outcomes primarily caused by the increased risks of prematurity and low birthweight associated with in vitro fertilization pregnancies. This Consult discusses the management of pregnancies achieved with in vitro fertilization and provides recommendations based on the available evidence. The recommendations by the Society for Maternal-Fetal Medicine are as follows: (1) we suggest that genetic counseling be offered to all patients undergoing or who have undergone in vitro fertilization with or without intracytoplasmic sperm injection (GRADE 2C); (2) regardless of whether preimplantation genetic testing has been performed, we recommend that all patients who have achieved pregnancy with in vitro fertilization be offered the options of prenatal genetic screening and diagnostic testing via chorionic villus sampling or amniocentesis (GRADE 1C); (3) we recommend that the accuracy of first-trimester screening tests, including cell-free DNA for aneuploidy, be discussed with patients undergoing or who have undergone in vitro fertilization (GRADE 1A); (4) when multifetal pregnancies do occur, we recommend that counseling be offered regarding the option of multifetal pregnancy reduction (GRADE 1C); (5) we recommend that a detailed obstetrical ultrasound examination (CPT 76811) be performed for pregnancies achieved with in vitro fertilization and intracytoplasmic sperm injection (GRADE 1B); (6) we suggest that fetal echocardiography be offered to patients with pregnancies achieved with in vitro fertilization and intracytoplasmic sperm injection (GRADE 2C); (7) we recommend that a careful examination of the placental location, placental shape, and cord insertion site be performed at the time of the detailed fetal anatomy ultrasound, including evaluation for vasa previa (GRADE 1B); (8) although visualization of the cervix at the 18 0/7 to 22 6/7 weeks of gestation anatomy assessment with either a transabdominal or endovaginal approach is recommended, we do not recommend serial cervical length assessment as a routine practice for pregnancies achieved with in vitro fertilization (GRADE 1C); (9) we suggest that an assessment of fetal growth be performed in the third trimester for pregnancies achieved with in vitro fertilization; however, serial growth ultrasounds are not recommended for the sole indication of in vitro fertilization (GRADE 2B); (10) we do not recommend low-dose aspirin for patients with pregnancies achieved with IVF as the sole indication for preeclampsia prophylaxis; however, if 1 or more additional risk factors are present, low-dose aspirin is recommended (GRADE 1B); (11) given the increased risk for stillbirth, we suggest weekly antenatal fetal surveillance beginning by 36 0/7 weeks of gestation for pregnancies achieved with in vitro fertilization (GRADE 2C); (12) in the absence of studies focused specifically on timing of delivery for pregnancies achieved with IVF, we recommend shared decision-making between patients and healthcare providers when considering induction of labor at 39 weeks of gestation (GRADE 1C).
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine, 2022·Fertility and Sterility
This committee opinion provides practitioners with suggestions for optimizing the likelihood of achieving pregnancy in couples or individuals attempting conception who have no evidence of infertility. This document replaces the document of the same name previously published in 2013 (Fertil Steril 2013;100:631-7).
Guidelines by Clinical Area · Obstetric Guidelines
This is the second edition of this guideline; the first edition was published in 2011 under the same name. It supplements NICE guideline NG25 Preterm labour and birth. Cerclage remains one of the standard options for prophylactic intervention in the care of women at risk of preterm birth and second trimester fetal loss and is used by most obstetricians, despite difficulties in identifying the population of women who would most benefit. The procedure, a stitch inserted into the cervix, was first performed in 1902 in women with a history of second trimester loss or spontaneous preterm birth suggestive of cervical insufficiency, with the aim of preventing recurrent loss. Cervical insufficiency is an imprecise clinical diagnosis frequently applied to women with such a history, where it is assumed that the cervix is ‘weak’ and unable to remain closed during the pregnancy. Recent evidence suggests that, rather than being a dichotomous variable, cervical integrity is likely to be a continuum influenced by factors related not solely to the intrinsic structure of the cervix but also to processes driving premature effacement and dilatation. While cerclage may provide a degree of structural support to a ‘weak’ cervix, its role in maintaining the cervical length and the endocervical mucus plug as a mechanical barrier to ascending infection may be more important. There is lack of consensus on the optimal cerclage technique, timing of suture placement, the role of amniocentesis before emergency cerclage insertion and optimal care following insertion. Complications are not well documented and often difficult to separate from risks inherent to the underlying condition. The purpose of this guideline is to review the literature and provide evidence-based guidance on the use of cerclage in women at risk of preterm birth and second trimester loss. This guideline supplements NICE guideline [NG25] Preterm labour and birth.1 Within this document we use the terms woman and women’s health. However, it is important to acknowledge that it is not only people who identify as women for whom it is necessary to access women’s health and reproductive services in order to maintain their gynaecological health and reproductive wellbeing. Gynaecological and obstetric services and delivery of care must therefore be appropriate, inclusive and sensitive to the needs of those individuals whose gender identity does not align with the sex they were assigned at birth. This Royal College of Obstetricians and Gynaecologists (RCOG) guideline was developed in accordance with the standard methodology for producing RCOG Green-top Guidelines.2 The Cochrane Library (including the Cochrane Database of Systematic Reviews), DARE, EMBASE, TRIP, Medline and PubMed (electronic databases) were searched for relevant randomized control trials, systematic reviews and meta-analyses. The search was restricted to articles published between 2011 and April 2020. The databases were searched using the relevant MeSH terms, including all subheadings and this was combined with a keyword search. Search words included ‘cervical cerclage’, ‘cervical suture’, ‘cervical stitch’, ‘midtrimester miscarriage’, ‘McDonald cerclage’, ‘Shirodkar cerclage’, ‘infection and cerclage’, ‘tocolytics and cerclage’ and ‘inflammatory mediators and cerclage’; the search was limited to humans and the English language. The National Library for Health and National Guidelines Clearing House were also searched for relevant guidelines and reviews. The full search strategy is available to view online as supporting information (Appendices S1 and S2). Previous terminology (prophylactic, as a planned procedure, emergency, urgent, rescue) of cervical sutures/cerclage can be ambiguous. More appropriate nomenclature based on indication for cervical suture is recommended. The terms below are increasingly used in the scientific literature. History-indicated cerclage Insertion of a cerclage as a result of factors in a woman’s obstetric or gynaecological history, which increase the risk of spontaneous second trimester loss or preterm birth.3 A history-indicated suture is performed as a prophylactic measure in asymptomatic women and usually inserted as a planned procedure at 11–14 weeks of gestation. Preterm Birth Birth before to 37+0 weeks’ gestation. Ultrasound-indicated cerclage Insertion of a cerclage as a therapeutic measure in cases of cervical length shortening seen on transvaginal ultrasound.3 Ultrasound-indicated cerclage is performed on asymptomatic women who do not have exposed fetal membranes in the vagina. Sonographic assessment of the cervix is usually performed between 14 and 24 weeks of gestation by transvaginal scan and with an empty maternal bladder.
Diagnostic Criteria and Classification · Diagnostic Criteria
Gregg AR et al., 2021·Genet Med·Free full text on PubMed Central
Carrier screening began 50 years ago with screening for conditions that have a high prevalence in defined racial/ethnic groups (e.g., Tay-Sachs disease in the Ashkenazi Jewish population; sickle cell disease in Black individuals). Cystic fibrosis was the first medical condition for which panethnic screening was recommended, followed by spinal muscular atrophy. Next-generation sequencing allows low cost and high throughput identification of sequence variants across many genes simultaneously. Since the phrase "expanded carrier screening" is nonspecific, there is a need to define carrier screening processes in a way that will allow equitable opportunity for patients to learn their reproductive risks using next-generation sequencing technology. An improved understanding of this risk allows patients to make informed reproductive decisions. Reproductive decision making is the established metric for clinical utility of population-based carrier screening. Furthermore, standardization of the screening approach will facilitate testing consistency. This practice resource reviews the current status of carrier screening, provides answers to some of the emerging questions, and recommends a consistent and equitable approach for offering carrier screening to all individuals during pregnancy or preconception.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org, 2021·Fertility and sterility
To provide evidence-based recommendations to practicing physicians and others regarding the efficacy of oocyte cryopreservation (OC) for donor oocyte in vitro fertilization and planned OC. The American Society for Reproductive Medicine conducted a literature search, which included systematic reviews, meta-analyses, randomized controlled trials, and prospective and retrospective comparative observational studies published from 1986 to 2018. The American Society for Reproductive Medicine Practice Committee and a task force of experts used available evidence and through consensus developed evidence-based guideline recommendations. MAIN OUTCOME MEASURE(S): Outcomes of interest included live birth rate, clinical pregnancy rate, obstetrical and neonatal outcomes, and factors predicting reproductive outcomes. RESULT(S): The literature search identified 30 relevant studies to inform the evidence base for this guideline. RECOMMENDATION(S): Evidence-based recommendations were developed for predicting the likelihood of live births after planned OC, autologous OC in infertile women, and donor OC, as well as factors that may impact live birth rates. Recommendations were developed regarding neonatal outcomes after using fresh vs. cryopreserved oocytes in cases of autologous or donor oocytes. CONCLUSION(S): There is insufficient evidence to predict live birth rates after planned OC. On the basis of limited data, ongoing and live birth rates appear to be improved for women who undergo planned OC at a younger vs. older age. Although there are no significant differences in per transfer pregnancy rates with cryopreserved vs. fresh donor oocytes, there is insufficient evidence that the live birth rate is the same with vitrified vs. fresh donor oocytes. Neonatal outcomes appear similar with cryopreserved oocytes compared with fresh oocytes. Future studies that compare cumulative live birth rates are needed.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine, 2021·Fertility and Sterility
This document reviews surgical options for reparative tubal surgery and the factors that must be considered when deciding between surgical repair and in vitro fertilization. This document replaces the document of the same name, last published in 2012 (Fertil Steril 2015;103:e37-43). This document reviews surgical options for reparative tubal surgery and the factors that must be considered when deciding between surgical repair and in vitro fertilization.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine et al., 2021·Fertility and sterility
This document is designed to provide a framework for assisted reproductive technology (ART) programs that meet or exceed the requirements suggested by the Centers for Disease Control and Prevention for certification of ART laboratories. This document replaces the document "Revised Minimum Standards for Practices Offering Assisted Reproductive Technologies: A Committee Opinion" published in 2019.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Knowledge about Klinefelter syndrome (KS) has increased substantially since its first description almost 80 years ago. A variety of treatment options concerning the spectrum of symptoms associated with KS exists, also regarding aspects beyond testicular dysfunction. Nevertheless, the diagnostic rate is still low in relation to prevalence and no international guidelines are available for KS.
To create the first European Academy of Andrology (EAA) guidelines on KS.
An expert group of academicians appointed by the EAA generated a consensus guideline according to the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system.
Clinical features are highly variable among patients with KS, although common characteristics are severely attenuated spermatogenesis and Leydig cell impairment, resulting in azoospermia and hypergonadotropic hypogonadism. In addition, various manifestations of neurocognitive and psychosocial phenotypes have been described as well as an increased prevalence of adverse cardiovascular, metabolic and bone-related conditions which might explain the increased morbidity/mortality in KS. Moreover, compared to the general male population, a higher prevalence of dental, coagulation and autoimmune disorders is likely to exist in patients with KS. Both genetic and epigenetic effects due to the supernumerary X chromosome as well as testosterone deficiency contribute to this pathological pattern. The majority of patients with KS is diagnosed during adulthood, but symptoms can already become obvious during infancy, childhood or adolescence. The paediatric and juvenile patients with KS require specific attention regarding their development and fertility.
These guidelines provide recommendations and suggestions to care for patients with KS in various developmental stages ranging from childhood and adolescence to adulthood. This advice is based on recent research data and respective evaluations as well as validations performed by a group of experts.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine, 2020·Fertility and sterility
Ovarian reserve is defined as the number of oocytes remaining in the ovary, or oocyte quantity (oocyte number). Markers of ovarian reserve include hormone levels and sonographically measured features of the ovaries. These markers can be useful as predictors of oocyte yield following controlled ovarian stimulation and oocyte retrieval. However, they are poor predictors of reproductive potential independently from age. This document replaces the document of the same name last published in 2012 (Fertil Steril 2012;98:1407-15).
Guidelines by Issuing Body · Specialty and Consensus Panels
Rabijewski M et al., 2020·Ginekol Pol·Free to read
Dehydroepiandrosterone (DHEA) concentration decreases with age, therefore, DHEA has been considered a hormone that reduces the symptoms associated with aging, so the usefulness of DHEA in premenopausal and postmenopausal women, and the options of hormone therapy have received a large amount of attention. The effectiveness of DHEA in the premenopausal women remains unclear, while in postmenopausal women with coexisting estrogens deficiency is controversial. Despite many years of study, the use of DHEA is still controversial, especially regarding its effectiveness. The aim of present article was to evaluate DHEA specific effects on metabolic parameters, bone mineral density, insulin resistance as well as the therapeutic potential of DHEA in preand postmenopausal women using measures of sexual activity, cognition and well-being. The summary of this article is the position statement of expert group of the Polish Menopause and Andropause Society regarding the efficacy and safety of DHEA supplementation in women. We concluded, that currently available clinical trials and meta-analyses indicate that DHEA supplementation is effective in women with adrenal insufficiency and chronically treated with exogenous glucocorticoids, postmenopausal women with low bone mineral density and/or osteoporosis, premenopausal women with sexual disorders and low libido, and in women with vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause. Currently available clinical trials also suggest that DHEA supplementation is probably effective in postmenopausal women with hypoactive sexual disorders, infertile women with diminished ovarian reserve, women suffering from depression and anxiety, and women with obesity and insulin resistance. No serious adverse effects have been reported.
Guidelines by Issuing Body · European and United Kingdom Bodies
Corona G et al., 2020·Journal of endocrinological investigation·Free full text on PubMed Central
The recent pandemic of severe acute respiratory syndrome (SARS) due to coronavirus (CoV) 2 (SARS-CoV-2) has raised several concerns in reproductive medicine. The aim of this review is to summarize available evidence providing an official position statement of the Italian Society of Andrology and Sexual Medicine (SIAMS) A comprehensive Pubmed, Web of Science, Embase, Medline and Cochrane library search was performed. Due to the limited evidence and the lack of studies, it was not possible to formulate recommendations according to the Oxford 2011 Levels of Evidence criteria.
Several molecular characteristics of the SARS-CoV-2 can justify the presence of virus within the testis and possible alterations of spermatogenesis and endocrine function. Orchitis has been reported as a possible complication of SARS-CoV infection, but similar findings have not been reported for SARS-CoV-2. Alternatively, the orchitis could be the result of a vasculitis as COVID-19 has been associated with abnormalities in coagulation and the segmental vascularization of the testis could account for an orchitis-like syndrome. Finally, available data do not support the presence of SARS-CoV-2 in plasma seminal fluid of infected subjects.
Data derived from other SARS-CoV infections suggest that in patients recovered from COVID-19, especially for those in reproductive age, andrological consultation and evaluation of gonadal function including semen analysis should be suggested. Studies in larger cohorts of currently infected subjects are warranted to confirm (or exclude) the presence of risks for male gametes that are destined either for cryopreservation in liquid nitrogen or for assisted reproduction techniques.
Guidelines by Clinical Area · Gynecologic Guidelines
Auclair MH et al., 2019·Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC
The aim of this guideline is to aid primary care physicians and gynaecologists in the initial evaluation of women with suspected endometrial hyperplasia, to recommend the use of the 2014 World Health Organization classification for endometrial hyperplasia by all health care providers, and to guide the optimal treatment of women diagnosed with endometrial hyperplasia.
Physicians, including gynaecologists, obstetricians, family physicians, general surgeons, emergency medicine specialists; nurses, including registered nurses and nurse practitioners; medical trainees, including medical students, residents, and fellows; and all other health care providers.
Adult women (18 years and older) presenting with suspected or confirmed endometrial hyperplasia.
The discussion relates to the medical therapy as well as surgical treatment options for women with and without atypical endometrial hyperplasia.
For this guideline, relevant studies were searched in PubMed, Cochrane Wiley, and the Cochrane Systematic Reviews using the following terms, either alone or in combination, with the search limited to English language materials, human subjects, and published since 2000: (endometrial hyperplasia, endometrial intraepithelial neoplasia, endometrial sampling, endometrial curettage, diagnosis) AND (treatment, progestin therapy, surgery, LNG-IUS, aromatase inhibitors, metformin ), AND (obesity). The search was performed in April 2018. Relevant evidence was selected for inclusion in the following order: meta-analyses, systematic reviews, guidelines, randomized controlled trials, prospective cohort studies, observational studies, non-systematic reviews, case series, and reports. Additional significant articles were identified through cross-referencing the identified reviews. The total number of studies identified was 2152, and 82 studies were included in this review.
The content and recommendations were drafted and agreed upon by the authors. The Executive and Board of the Society of Gynecologic Oncology of Canada reviewed the content and submitted comments for consideration, and the Board of the Society of Obstetricians and Gynaecologists of Canada approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology framework. The interpretation of strong and weak recommendations was also included. The Summary of Findings is available upon request.
BENEFITS, HARMS, It is expected that this guideline will benefit women with endometrial hyperplasia. This should guide patient informed consent before both medical and surgical management of this condition.
Evidence will be reviewed 5 years after publication to decide whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations.
RECOMMENDATIONS.
Guidelines by Clinical Area · Obstetric Guidelines
Perinatal palliative care refers to a coordinated care strategy that comprises options for obstetric and newborn care that include a focus on maximizing quality of life and comfort for newborns with a variety of conditions considered to be life-limiting in early infancy. With a dual focus on ameliorating suffering and honoring patient values, perinatal palliative care can be provided concurrently with life-prolonging treatment. The focus of this document, however, involves the provision of exclusively palliative care without intent to prolong life in the context of a life-limiting condition, otherwise known as perinatal palliative comfort care. Once a life-limiting diagnosis is suspected antenatally, the tenets of informed consent require that the pregnant patient be given information of sufficient depth and breadth to make an informed, voluntary choice for her care. Health care providers are encouraged to model effective, compassionate communication that respects patient cultural beliefs and values and to promote shared decision making with patients. Perinatal palliative comfort care is one of several options along a spectrum of care, which includes pregnancy termination (abortion) and full neonatal resuscitation and treatment, that should be presented to pregnant patients faced with pregnancies complicated by life-limiting fetal conditions. If a patient opts to pursue perinatal palliative comfort care, a multidisciplinary team should be identified with the infrastructure and support to administer this care. The perinatal palliative care team should prepare families for the possibility that there may be differences of opinion between family members before and after the delivery of the infant, and that there may be differences between parents and the neonatal care providers about appropriate postnatal therapies, especially if the postnatal diagnosis and prognosis differ substantially from antenatal predictions. Procedures for resolving such differences should be discussed with families ahead of time.
Guideline Appraisal · Evidence Base and Strength of Recommendation
A recent cross-sectional national USA registry of surgery to repair anterior cruciate ligament tears found that fewer adolescent women who reported using combined hormonal contraceptives (CHC) had the surgery. They reviewed a complex literature on ovarian steroidal relationships with connective tissues biology, physiology and clinical issues. They concluded, based on their data and that evidence shows the greatest gender imbalance for women's ACL injury during adolescence, that all adolescent athletic women should be treated with CHC to prevent ACL injury. We caution that this admonition is using association to imply causation, implies we understand the ovarian hormonal relationships with connective tissues while that remains unclear, the directive to use CHC in adolescent ignores the recent meta-analytic evidence that its use is associated with failure to achieve peak bone mass and that these authors have used erroneous inferential reasoning and ignored the other variables besides sex and age related to ACL injury and the convincing evidence that training strategies can prevent tears.
Guidelines by Clinical Area · Gynecologic Guidelines
American College of Obstetricians and Gynecologists, 2019·Obstetrics and gynecology
Opportunistic salpingectomy may offer obstetrician-gynecologists and other health care providers the opportunity to decrease the risk of ovarian cancer in their patients who are already undergoing pelvic surgery for benign disease. By performing salpingectomy when patients undergo an operation during which the fallopian tubes could be removed in addition to the primary surgical procedure (eg, hysterectomy), the risk of ovarian cancer is reduced. Although opportunistic salpingectomy offers the opportunity to significantly decrease the risk of ovarian cancer, it does not eliminate the risk of ovarian cancer entirely. Counseling women who are undergoing routine pelvic surgery about the risks and benefits of salpingectomy should include an informed consent discussion about the role of oophorectomy and bilateral salpingo-oophorectomy. Bilateral salpingo-oophorectomy that causes surgical menopause reduces the risk of ovarian cancer but may increase the risk of cardiovascular disease, cancer other than ovarian cancer, osteoporosis, cognitive impairment, and all-cause mortality. Salpingectomy at the time of hysterectomy or as a means of tubal sterilization appears to be safe and does not increase the risk of complications such as blood transfusions, readmissions, postoperative complications, infections, or fever compared with hysterectomy alone or tubal ligation. The risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization. Additionally, ovarian function does not appear to be affected by salpingectomy at the time of hysterectomy based on surrogate serum markers or response to in vitro fertilization. Plans to perform an opportunistic salpingectomy should not alter the intended route of hysterectomy. Obstetrician-gynecologists should continue to observe and practice minimally invasive techniques. This Committee Opinion has been updated to include new information on the benefit of salpingectomy for cancer reduction, the feasibility of salpingectomy during vaginal hysterectomy, and long-term follow-up of women after salpingectomy.
Guidelines by Clinical Area · Contraception Eligibility Criteria
Although numerous studies have addressed the safety and effectiveness of hormonal contraceptive use in healthy women, data regarding women with underlying medical conditions or other special circumstances are limited. The U.S. Medical Eligibility Criteria (USMEC) for Contraceptive Use, 2016 (), which has been endorsed by the American College of Obstetricians and Gynecologists, is a published guideline based on the best available evidence and expert opinion to help health care providers better care for women with chronic medical problems who need contraception. The goal of this Practice Bulletin is to explain how to use the USMEC rating system in clinical practice and to specifically discuss the rationale behind the ratings for various medical conditions. Contraception for women with human immunodeficiency virus (HIV) (); the use of emergency contraception in women with medical coexisting medical conditions, including obesity, (); and the effect of depot medroxyprogesterone acetate (DMPA) on bone health () are addressed in other documents from the American College of Obstetricians and Gynecologists.
Diagnostic Criteria and Classification · Staging and Classification Systems
Duffy KA et al., 2019·American journal of medical genetics. Part C, Seminars in medical genetics·Free full text on PubMed Central
Beckwith-Wiedemann syndrome (BWS) is the most common epigenetic overgrowth and cancer predisposition disorder. Due to both varying molecular defects involving chromosome 11p15 and tissue mosaicism, patients can present with a variety of clinical features, leading to the newly defined Beckwith-Wiedemann spectrum (BWSp). The BWSp can be further divided into three subsets of those presenting with classic features, those presenting with isolated lateralized overgrowth (ILO) and those not fitting into the previous two categories, termed atypical BWSp. Previous reports of patients with BWS have focused on those with the more recognizable, classic features, and limited information is available on those who fit into the atypical and ILO categories. Here, we present the first cohort of patients recruited across the entire BWSp, describe clinical features and molecular diagnostic characteristics, and provide insight into practical diagnosis and management recommendations that we have gained from this cohort.
Guidelines by Clinical Area · Obstetric Guidelines
American College of Obstetricians and Gynecologists et al., 2018·Obstetrics & Gynecology
Placenta accreta spectrum, formerly known as morbidly adherent placenta, refers to the range of pathologic adherence of the placenta, including placenta increta, placenta percreta, and placenta accreta. The most favored hypothesis regarding the etiology of placenta accreta spectrum is that a defect of the endometrial-myometrial interface leads to a failure of normal decidualization in the area of a uterine scar, which allows abnormally deep placental anchoring villi and trophoblast infiltration. Maternal morbidity and mortality can occur because of severe and sometimes life-threatening hemorrhage, which often requires blood transfusion. Although ultrasound evaluation is important, the absence of ultrasound findings does not preclude a diagnosis of placenta accreta spectrum; thus, clinical risk factors remain equally important as predictors of placenta accreta spectrum by ultrasound findings. There are several risk factors for placenta accreta spectrum. The most common is a previous cesarean delivery, with the incidence of placenta accreta spectrum increasing with the number of prior cesarean deliveries. Antenatal diagnosis of placenta accreta spectrum is highly desirable because outcomes are optimized when delivery occurs at a level III or IV maternal care facility before the onset of labor or bleeding and with avoidance of placental disruption. The most generally accepted approach to placenta accreta spectrum is cesarean hysterectomy with the placenta left in situ after delivery of the fetus (attempts at placental removal are associated with significant risk of hemorrhage). Optimal management involves a standardized approach with a comprehensive multidisciplinary care team accustomed to management of placenta accreta spectrum. In addition, established infrastructure and strong nursing leadership accustomed to managing high-level postpartum hemorrhage should be in place, and access to a blood bank capable of employing massive transfusion protocols should help guide decisions about delivery location.
Diagnostic Criteria and Classification · Staging and Classification Systems
The International Federation of Gynecology and Obstetrics (FIGO) systems for nomenclature of symptoms of normal and abnormal uterine bleeding (AUB) in the reproductive years (FIGO AUB System 1) and for classification of causes of AUB (FIGO AUB System 2; PALM-COEIN) were first published together in 2011. The purpose was to harmonize the definitions of normal and abnormal bleeding symptoms and to classify and subclassify underlying potential causes of AUB in the reproductive years to facilitate research, education, and clinical care. The systems were designed to be flexible and to be periodically reviewed and modified as appropriate. To review, clarify, and, where appropriate, revise the previously published systems. To a large extent, the process has been an iterative one involving the FIGO Menstrual Disorders Committee, as well as a number of invited contributions from epidemiologists, gynecologists, and other experts in the field from around the world between 2012 and 2017. Face-to-face meetings have been held in Rome, Vancouver, and Singapore, and have been augmented by a number of teleconferences and other communications designed to evaluate various aspects of the systems. Where substantial change was considered, anonymous voting, in some instances using a modified RAND Delphi technique, was utilized.
Diagnostic Criteria and Classification · Terminology and Definitions
Zegers-Hochschild F et al., 2017·Hum Reprod·Free full text on PubMed Central
Can a consensus and evidence-driven set of terms and definitions be generated to be used globally in order to ensure consistency when reporting on infertility issues and fertility care interventions, as well as to harmonize communication among the medical and scientific communities, policy-makers, and lay public including individuals and couples experiencing fertility problems? A set of 283 consensus-based and evidence-driven terminologies used in infertility and fertility care has been generated through an inclusive consensus-based process with multiple stakeholders. In 2006 the International Committee for Monitoring Assisted Reproductive Technologies (ICMART) published a first glossary of 53 terms and definitions. In 2009 ICMART together with WHO published a revised version expanded to 87 terms, which defined infertility as a disease of the reproductive system, and increased standardization of fertility treatment terminology. Since 2009, limitations were identified in several areas and enhancements were suggested for the glossary, especially concerning male factor, demography, epidemiology and public health issues. STUDY DESIGN, SIZE, Twenty-five professionals, from all parts of the world and representing their expertise in a variety of sub-specialties, were organized into five working groups: clinical definitions; outcome measurements; embryology laboratory; clinical and laboratory andrology; and epidemiology and public health. Assessment for revisions, as well as expansion on topics not covered by the previous glossary, were undertaken. A larger group of independent experts and representatives from collaborating organizations further discussed and assisted in refining all terms and definitions. PARTICIPANTS/MATERIALS, SETTING, Members of the working groups and glossary co-ordinators interacted through electronic mail and face-to-face in international/regional conferences. Two formal meetings were held in Geneva, Switzerland, with a final consensus meeting including independent experts as well as observers and representatives of international/regional scientific and patient organizations. MAIN A consensus-based and evidence-driven set of 283 terminologies used in infertility and fertility care was generated to harmonize communication among health professionals and scientists as well as the lay public, patients and policy makers. Definitions such as 'fertility care' and 'fertility awareness' together with terminologies used in embryology and andrology have been introduced in the glossary for the first time. Furthermore, the definition of 'infertility' has been expanded in order to cover a wider spectrum of conditions affecting the capacity of individuals and couples to reproduce. The definition of infertility remains as a disease characterized by the failure to establish a clinical pregnancy; however, it also acknowledges that the failure to become pregnant does not always result from a disease, and therefore introduces the concept of an impairment of function which can lead to a disability. Additionally, subfertility is now redundant, being replaced by the term infertility so as to standardize the definition and avoid confusion. LIMITATIONS, All stakeholders agreed to the vast majority of terminologies included in this glossary. In cases where disagreements were not resolved, the final decision was reached after a vote, defined before the meeting as consensus if passed with 75%. Over the following months, an external expert group, which included representatives from non-governmental organizations, reviewed and provided final feedback on the glossary. Some terminologies have different definitions, depending on the area of medicine, for example demographic or clinical as well as geographic differences. These differences were taken into account and this glossary represents a multinational effort to harmonize terminologies that should be used worldwide. None. N/A.
Guidelines by Clinical Area · Obstetric Guidelines
Carrier screening is a term used to describe genetic testing that is performed on an individual who does not have any overt phenotype for a genetic disorder but may have one variant allele within a gene(s) associated with a diagnosis. Information about carrier screening should be provided to every pregnant woman. Carrier screening and counseling ideally should be performed before pregnancy because this enables couples to learn about their reproductive risk and consider the most complete range of reproductive options. A patient may decline any or all screening. When an individual is found to be a carrier for a genetic condition, his or her relatives are at risk of carrying the same mutation. The patient should be encouraged to inform his or her relatives of the risk and the availability of carrier screening. If an individual is found to be a carrier for a specific condition, the patient's reproductive partner should be offered testing in order to receive informed genetic counseling about potential reproductive outcomes. If both partners are found to be carriers of a genetic condition, genetic counseling should be offered. What follows is a detailed discussion of some of the more common genetic conditions for which carrier screening is recommended in at least some segments of the population.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society for Reproductive Endocrinology and Infertility, 2017·Fertil Steril
This Committee Opinion provides practitioners with suggestions for optimizing the likelihood of achieving pregnancy in couples/individuals attempting conception who have no evidence of infertility. This document replaces the document of the same name previously published in 2013, Fertil Steril 2013;100(3):631-7.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine and Practice Committee of the Society for Assisted Reproductive Technology, 2017·Fertility and sterility
This document provides the latest recommendations for evaluation of gestational carriers and intended parents. It incorporates recent information from the US Centers for Disease Control and Prevention, the US Food and Drug Administration, and the American Association of Tissue Banks, with which all programs offering gestational carrier services must be thoroughly familiar. This document replaces the previous document of the same name, last published in 2015 (Fertil Steril® 2015; 103:e1-8).
Guidelines by Clinical Area · Fertility and Infertility Guidelines
American College of Obstetricians and Gynecologists, 2016·Obstetrics and Gynecology
Over the past decades, the use of assisted reproductive technology (ART) has increased dramatically worldwide and has made pregnancy possible for many infertile couples. Although the perinatal risks that may be associated with ART and ovulation induction are much higher in multifetal gestations, even singletons achieved with ART and ovulation induction may be at higher risk than singletons from naturally occurring pregnancies. However, it remains unclear to what extent these associations might be related to the underlying cause(s) of infertility. Before initiating ART or ovulation induction procedures, obstetrician-gynecologists and other health care providers should complete a thorough medical evaluation to ensure that patients are in good health and should counsel these women about the risks associated with treatment. Any maternal health problems or inherited conditions should be addressed. Couples at risk of passing genetic conditions on to their offspring, including those due to infertility-associated conditions, should be counseled appropriately. When a higher-order (triplet or more) multifetal pregnancy is encountered, the option of multifetal reduction should be discussed. In the case of a continuing higher-order multifetal pregnancy, ongoing obstetric care should be with an obstetrician-gynecologist or other obstetric care provider and at a facility capable of managing anticipated risks and outcomes.
Guidelines by Issuing Body · United States Professional Societies
Ethics Committee of the American Society for Reproductive Medicine, 2016·Fertility and sterility
This opinion addresses the ethics of providing fertility treatment to women at elevated risk from fertility treatment or pregnancy. Providers ethically may treat women at elevated risk provided that they are carefully assessed; that specialists in their medical condition are consulted as appropriate; and that patients are fully informed about risks, benefits, and alternatives, including oocyte and embryo donation, use of a gestational surrogate, not undergoing fertility care, and adoption. Providers also may conclude that the risks are too high for them to treat particular patients ethically; such determinations must be made in a medically objective and unbiased manner and patients must be fully informed of the decision. Counseling of women who wish to initiate fertility treatment with underlying medical conditions that confer increased risk during treatment or pregnancy should incorporate the most current knowledge available, being cognizant of the woman's personal determinants in relation to her reproductive desires. In such a way, both physician and patient will optimize decision making in an ethically sound, patient-supportive context.
Guidelines by Clinical Area · Gynecologic Guidelines
Despite variations worldwide and within the U.S. population, median age at menarche has remained relatively stable-between 12 years and 13 years-across well-nourished populations in developed countries. Environmental factors, including socioeconomic conditions, nutrition, and access to preventive health care, may influence the timing and progression of puberty. A number of medical conditions can cause abnormal uterine bleeding, characterized by unpredictable timing and variable amount of flow. Clinicians should educate girls and their caretakers (eg, parents or guardians) about what to expect of a first menstrual period and the range for normal cycle length of subsequent menses. Identification of abnormal menstrual patterns in adolescence may improve early identification of potential health concerns for adulthood. It is important for clinicians to have an understanding of the menstrual patterns of adolescent girls, the ability to differentiate between normal and abnormal menstruation, and the skill to know how to evaluate the adolescent girl patient. By including an evaluation of the menstrual cycle as an additional vital sign, clinicians reinforce its importance in assessing overall health status for patients and caretakers.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Ethics Committee of the American Society for Reproductive Medicine, 2015·Fertility and Sterility
The purpose of this ASRM Practice Committee report is to provide clinicians with principles and strategies for the evaluation and treatment of couples with infertility associated with obesity. This revised document replaces the Practice Committee document titled, "Obesity and reproduction: an educational bulletin," last published in 2008 (Fertil Steril 2008;90:S21-9).
Guidelines by Clinical Area · Contraception Eligibility Criteria
Emergency contraception, also known as postcoital contraception, is therapy used to prevent pregnancy after an unprotected or inadequately protected act of sexual intercourse. Common indications for emergency contraception include contraceptive failure (eg, condom breakage or missed doses of oral contraceptives) and failure to use any form of contraception (1-3). Although oral emergency contraception was first described in the medical literature in the 1960s, the U.S. Food and Drug Administration (FDA) approved the first dedicated product for emergency contraception in 1998. Since then, several new products have been introduced. Methods of emergency contraception include oral administration of combined estrogen-progestin, progestin only, or selective progesterone receptor modulators and insertion of a copper intrauterine device (IUD). Many women are unaware of the existence of emergency contraception, misunderstand its use and safety, or do not use it when a need arises (4-6). The purpose of this Practice Bulletin is to review the evidence for the efficacy and safety of available methods of emergency contraception and to increase awareness of these methods among obstetrician-gynecologists and other gynecologic providers.
Guidelines by Clinical Area · Gynecologic Guidelines
Mortality from ovarian cancer may be dramatically reduced with the implementation of attainable prevention strategies. The new understanding of the cells of origin and the molecular etiology of ovarian cancer warrants a strong recommendation to the public and health care providers. This document discusses potential prevention strategies, which include 1) oral contraceptive use, 2) tubal sterilization, 3) risk-reducing salpingo-oophorectomy in women at high hereditary risk of breast and ovarian cancer, 4) genetic counseling and testing for women with ovarian cancer and other high-risk families, and 5) salpingectomy after childbearing is complete (at the time of elective pelvic surgeries, at the time of hysterectomy, and as an alternative to tubal ligation). The Society of Gynecologic Oncology has determined that recent scientific breakthroughs warrant a new summary of the progress toward the prevention of ovarian cancer. This review is intended to emphasize the importance of the fallopian tubes as a potential source of high-grade serous cancer in women with and without known genetic mutations in addition to the use of oral contraceptive pills to reduce the risk of ovarian cancer.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine, 2015·Fertil Steril
This document reviews surgical options for achieving patency in obstructed fallopian tubes and the factors that must be considered when deciding between surgical repair and IVF. This document replaces the document of the same name, last published in 2012 (Fertil Steril 2012;97:539–45).
Guidelines by Issuing Body · United States Professional Societies
Ethics Committee of American Society for Reproductive Medicine, 2015·Fertility and sterility
The introduction of new strategies, tests and procedures into clinical practice raises challenging ethical issues involving evaluation of evidence, balancing benefits and harms, supporting patient autonomy, avoiding conflict of interest, and promoting advances in health care. The purpose of this document is to assist reproductive health practitioners as they introduce new interventions into the clinical care that they provide to patients.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Ethics Committee of American Society for Reproductive Medicine, 2015·Fertility and sterility
Human immunodeficiency virus (HIV) is a serious but manageable chronic disease that affects persons of reproductive age, many of whom express a desire for biologic parenthood. This document is a revision of the original document of the same name, last published in 2010 (Fertil Steril 2010;94:11-5).
Guidelines by Clinical Area · Bone and Endocrine Guidelines
Isidori AM et al., 2015·Journal of endocrinological investigation·Free full text on PubMed Central
We developed clinical practice guidelines to assess the individual risk-benefit profile of androgen replacement therapy in adult male hypogonadism (HG), defined by the presence of specific signs and symptoms and serum testosterone (T) below 12 nmol/L.
The task force consisted of eight clinicians experienced in treating HG, selected by the Italian Society of Endocrinology (SIE). The authors received no corporate funding or remuneration.
Consensus was guided by a systematic review of controlled trials conducted on men with a mean T < 12 nmol/L and by interactive discussions. The guidelines were reviewed and sequentially approved by the SIE Guidelines Commission and Executive Committee.
We recommend T supplementation (TS) for adult men with severely reduced T levels (T < 8 nmol/L) to improve body composition and sexual function. We suggest that TS be offered to subjects with T < 12 nmol/L to improve glycaemic control, lipid profile, sexual function, bone mineral density, muscle mass and depressive symptoms, once major contraindications have been ruled out. We suggest that lifestyle changes and other available interventions (e.g. for erectile dysfunction) be suggested prior to TS. We suggest that TS should be combined with currently available treatments for individuals at high risk for complications, such as those with osteoporosis and/or metabolic disorders. We recommend against using TS to improve cardiac outcome and limited mobility. We recommend against using TS in men with prostate cancer, unstable cardiovascular conditions or elevated haematocrit. The task force places a high value on the timely treatment of younger and middle-aged subjects to prevent the long-term consequences of hypoandrogenism.
Guidelines by Clinical Area · Gynecologic Guidelines
This report updates CDC's 2002 recommendations regarding screening tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections (CDC. Screening tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections-2002. MMWR 2002;51[No. RR-15]) and provides new recommendations regarding optimal specimen types, the use of tests to detect rectal and oropharyngeal C. trachomatis and N. gonorrhoeae infections, and circumstances when supplemental testing is indicated. The recommendations in this report are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available tests, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients. The performance of nucleic acid amplification tests (NAATs) with respect to overall sensitivity, specificity, and ease of specimen transport is better than that of any of the other tests available for the diagnosis of chlamydial and gonococcal infections. Laboratories should use NAATs to detect chlamydia and gonorrhea except in cases of child sexual assault involving boys and rectal and oropharyngeal infections in prepubescent girls and when evaluating a potential gonorrhea treatment failure, in which case culture and susceptibility testing might be required. NAATs that have been cleared by the Food and Drug Administration (FDA) for the detection of C. trachomatis and N. gonorrhoeae infections are recommended as screening or diagnostic tests because they have been evaluated in patients with and without symptoms. Maintaining the capability to culture for both N. gonorrhoeae and C. trachomatis in laboratories throughout the country is important because data are insufficient to recommend nonculture tests in cases of sexual assault in prepubescent boys and extragenital anatomic site exposure in prepubescent girls. N. gonorrhoeae culture is required to evaluate suspected cases of gonorrhea treatment failure and to monitor developing resistance to current treatment regimens. Chlamydia culture also should be maintained in some laboratories to monitor future changes in antibiotic susceptibility and to support surveillance and research activities such as detection of lymphogranuloma venereum or rare infections caused by variant or mutated C. trachomatis.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
American College of Obstetricians and Gynecologists Committee on Gynecologic Practice and Practice Committee, 2014·Fertility and sterility
The fecundity of women decreases gradually but significantly beginning approximately at age 32 years and decreases more rapidly after age 37 years. Education and enhanced awareness of the effect of age on fertility are essential in counseling the patient who desires pregnancy. Given the anticipated age-related decline in fertility, the increased incidence of disorders that impair fertility, and the higher risk of pregnancy loss, women older than 35 years should receive an expedited evaluation and undergo treatment after 6 months of failed attempts to conceive or earlier, if clinically indicated. In women older than 40 years, more immediate evaluation and treatment are warranted.
Guidelines by Clinical Area · Gynecologic Guidelines
Initial evaluation of the patient with acute abnormal uterine bleeding should include a prompt assessment for signs of hypovolemia and potential hemodynamic instability. After initial assessment and stabilization, the etiologies of acute abnormal uterine bleeding should be classified using the PALM-COEIN system. Medical management should be the initial treatment for most patients, if clinically appropriate. Options include intravenous conjugated equine estrogen, multi-dose regimens of combined oral contraceptives or oral progestins, and tranexamic acid. Decisions should be based on the patient's medical history and contraindications to therapies. Surgical management should be considered for patients who are not clinically stable, are not suitable for medical management, or have failed to respond appropriately to medical management. The choice of surgical management should be based on the patient's underlying medical conditions, underlying pathology, and desire for future fertility. Once the acute bleeding episode has been controlled, transitioning the patient to long-term maintenance therapy is recommended.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Practice Committee of the American Society for Reproductive Medicine, 2012·Fertil Steril
The majority of miscarriages are sporadic and most result from genetic causes that are greatly influenced by maternal age. Recurrent pregnancy loss (RPL) is defined by two or more failed clinical pregnancies, and up to 50% of cases of RPL will not have a clearly defined etiology.
Diagnostic Criteria and Classification · Terminology and Definitions
Lix LM et al., 2012·BMC Public Health·Free full text on PubMed Central
Population-based administrative data have been used to study osteoporosis-related fracture risk factors and outcomes, but there has been limited research about the validity of these data for ascertaining fracture cases. The objectives of this study were to: (a) compare fracture incidence estimates from administrative data with estimates from population-based clinically-validated data, and (b) test for differences in incidence estimates from multiple administrative data case definitions. Thirty-five case definitions for incident fractures of the hip, wrist, humerus, and clinical vertebrae were constructed using diagnosis codes in hospital data and diagnosis and service codes in physician billing data from Manitoba, Canada. Clinically-validated fractures were identified from the Canadian Multicentre Osteoporosis Study (CaMos). Generalized linear models were used to test for differences in incidence estimates. For hip fracture, sex-specific differences were observed in the magnitude of underand over-ascertainment of administrative data case definitions when compared with CaMos data. The length of the fracture-free period to ascertain incident cases had a variable effect on over-ascertainment across fracture sites, as did the use of imaging, fixation, or repair service codes. Case definitions based on hospital data resulted in under-ascertainment of incident clinical vertebral fractures. There were no significant differences in trend estimates for wrist, humerus, and clinical vertebral case definitions. The validity of administrative data for estimating fracture incidence depends on the site and features of the case definition.
Diagnostic Criteria and Classification · Staging and Classification Systems
Munro MG et al., 2011·International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics
There is general inconsistency in the nomenclature used to describe abnormal uterine bleeding (AUB), in addition to a plethora of potential causes-several of which may coexist in a given individual. It seems clear that the development of consistent and universally accepted nomenclature is a step toward rectifying this unsatisfactory circumstance. Another requirement is the development of a classification system, on several levels, for the causes of AUB, which can be used by clinicians, investigators, and even patients to facilitate communication, clinical care, and research. This manuscript describes an ongoing process designed to achieve these goals, and presents for consideration the PALM-COEIN (polyp; adenomyosis; leiomyoma; malignancy and hyperplasia; coagulopathy; ovulatory dysfunction; endometrial; iatrogenic; and not yet classified) classification system for AUB, which has been approved by the International Federation of Gynecology and Obstetrics (FIGO) Executive Board as a FIGO classification system.
Diagnostic Criteria and Classification · Staging and Classification Systems
There is a need for a better etiologic classification of preterm births and for tools to help to determine the possible etiologies of these births. Having previously developed the Barcelona Etiology of Prematurity (BEP) algorithm, based on a new classification for preterm births, we sought to validate this algorithm in clinical studies whereby doctors retrospectively assigned the etiology of preterm birth according to principal cause and associated causes. In phase 1 of the study, 91 preterm neonates consecutively admitted to a tertiary hospital were etiologically classified by doctors using the BEP algorithm. In phase 2, another 29 cases, representing the full spectrum of standard clinical scenarios, were classified by 20 doctors randomly divided into two groups of 10: one group used the algorithm and the other did not. In phase 1, the doctors were able to assign the etiology of all 91 clinical cases using the BEP algorithm, showing a 95.6% level of agreement with the etiologies set by the authors. In phase 2, for the 572 total evaluations, the group that used the BEP algorithm had significantly fewer errors in assigning the principal cause of prematurity than the group that did not use the algorithm (4.51 vs. 16.20%, respectively; p < 0.0001), and also demonstrated a higher level of correlation in assigning the associated causes. The proposed classification may be used to retrospectively categorize the etiology of preterm births, and the BEP algorithm facilitates this task enabling greater accuracy and precision in clinical data.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group, 2008·Fertility and Sterility
The treatment of infertile women with polycystic ovary syndrome (PCOS) is surrounded by many controversies. On the basis of the currently available evidence, a group of experts reached a consensus regarding the therapeutic challenges raised in these women. Before any intervention is initiated, preconceptional counseling should be provided emphasizing the importance of lifestyle, especially weight reduction and exercise in overweight women, smoking, and alcohol consumption. The recommended first-line treatment for ovulation induction remains the anti-estrogen clomiphene citrate (CC). Recommended second-line intervention, should CC fail to result in pregnancy, is either exogenous gonadotropins or laparoscopic ovarian surgery (LOS). The use of exogenous gonadotropins is associated with increased chances for multiple pregnancy, and, therefore, intense monitoring of ovarian response is required. Laparoscopic ovarian surgery alone is usually effective in less than 50% of women, and additional ovulation induction medication is required under those circumstances. Overall, ovulation induction (representing the CC-gonadotropin paradigm) is reported to be highly effective with a cumulative singleton live-birth rate of 72%. Recommended third-line treatment is in vitro fertilization (IVF). More patient-tailored approaches should be developed for ovulation induction based on initial screening characteristics of women with PCOS. Such approaches may result in deviation from the above mentioned first-line, second-line, or third-line ovulation strategies in well-defined subsets of patients. Metformin use in PCOS should be restricted to women with glucose intolerance. Based on recent data available in the literature, the routine use of this drug in ovulation induction is not recommended. Insufficient evidence is currently available to recommend the clinical use of aromatase inhibitors for routine ovulation induction. Even singleton pregnancies in PCOS are associated with increased health risk for both the mother and the fetus.
Guidelines by Issuing Body · Specialty and Consensus Panels
At the 2007 Position Development Conference, the Dual-Energy X-ray Absorptiometry Technical Task Force investigated three major areas of bone density testing. Although bone mineral density (BMD) testing in men had previously been reviewed at the 2005 Position Development Conference, we reviewed the most recent data in men to develop appropriate indications for bone density testing in men. We continue to recommend screening at age 70 and discuss the clinical risk factors that may be an appropriate indication for earlier BMD testing. Menopausal transition (perimenopause) was considered an important time to consider BMD evaluation because bone loss may be significant prior to menopause. However, because fracture risk is inherently low in women of this age without other risk factors, screening BMD testing is not appropriate. We discuss the risk factors that are strong indicators of fracture risk that may be increased during the menopause transition. The presence of these risk factors are appropriate indications for BMD testing with applicability of WHO diagnostic categorization. The issue of establishing a high threshold for BMD was investigated thoroughly and the current literature was reviewed. Despite the fact there is agreement that all BMD values greater than T-score -1.0 are not normal, it was felt that because of the paucity of sensitivity data and confounding factors such as high body mass index, an upper threshold could not be established or recommended at this time. This was felt to be an important area for further research.
Guidelines by Issuing Body · Specialty and Consensus Panels
von Elm E et al., 2007·PLoS Med·Free full text on PubMed Central
Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
Diagnostic Criteria and Classification · Terminology and Definitions
There is considerable worldwide confusion in the use of terminologies and definitions around the symptom of abnormal uterine bleeding (AUB), and these are leading increasingly to difficulties in setting up multinational clinical trials and in interpreting the results of studies undertaken in single centres. An international initiative was established to develop an agreement process to recommend clear, simple terminologies and definitions with the potential for wide acceptance. After widespread consultation with relevant international and national organizations, journal editors and individuals, a modified Delphi process was developed to assess the current use of terminologies followed by a structured face-to-face meeting of 35 clinicians (mostly gynaecologists) and scientists in Washington. Focused small group discussions led to plenary assessment of concepts and recommendations using an electronic keypad voting system. There was almost universal agreement that poorly defined terms of classical origin used in differing ways in the English medical language should be discarded and that these should be replaced by simple, descriptive terms with clear definitions which have the potential to be understood by health professional and patient alike and which can be translated into most languages. The major recommendations were to replace terms such as menorrhagia, metrorrhagia, hypermenorrhoea and dysfunctional uterine bleeding. Suggestions for potentially suitable replacement terms and definitions are made. A simple terminology has been recommended for the description and definition of symptoms and signs of AUB. This manuscript should be a living document and should be part of an ongoing process with international medical and community debate. Classification of causes, investigations and cultural and quality of life issues should be part of the ongoing process.
Guidelines by Clinical Area · Obstetric Guidelines
Brown JP et al., 2002·CMAJ·Free full text on PubMed Central
To revise and expand the 1996 Osteoporosis Society of Canada clinical practice guidelines for the management of osteoporosis, incorporating recent advances in diagnosis, prevention and management of osteoporosis, and to identify and assess the evidence supporting the recommendations. Options: All aspects of osteoporosis care and its fracture complications - including classification, diagnosis, management and methods for screening, as well as prevention and reducing fracture risk - were reviewed, revised as required and expressed as a set of recommendations. Outcomes: Strategies for identifying and evaluating those at high risk; the use of bone mineral density and biochemical markers in diagnosis and assessing response to management; recommendations regarding nutrition and physical activity; and the selection of pharmacologic therapy for the prevention and management of osteoporosis in men and women and for osteoporosis resulting from glucocorticoid treatment. Evidence: All recommendations were developed using a justifiable and reproducible process involving an explicit method for the evaluation and citation of supporting evidence. Values: All recommendations were reviewed by members of the Scientific Advisory Council of the Osteoporosis Society of Canada, an expert steering committee and others, including family physicians, dietitians, therapists and representatives of various medical specialties involved in osteoporosis care (geriatric medicine, rheumatology, endocrinology, obstetrics and gynecology, nephrology, radiology) as well as methodologists from across Canada. BENEFITS, Harm and Costs: Earlier diagnosis and prevention of fractures should decrease the medical, social and economic burdens of this disease. Recommendations: This document outlines detailed recommendations pertaining to all aspects of osteoporosis. Strategies for identifying those at increased risk (i.e., those with at least one major or 2 minor risk factors) and screening with central dual-energy x-ray absorptiometry at age 65 years are recommended. Bisphosphonates and raloxifene are first-line therapies in the prevention and treatment of postmenopausal osteoporosis. Estrogen and progestin/progesterone is a first-line therapy in the prevention and a second-line therapy in the treatment of postmenopausal osteoporosis. Nasal calcitonin is a second-line therapy in the treatment of postmenopausal osteoporosis. Although not yet approved for use in Canada, hPTH(1-34) is expected to be a first-line treatment for postmenopausal women with severe osteoporosis. Ipriflavone, vitamin K and fluoride are not recommended. Bisphosphonates are the first-line therapy for the prevention and treatment of osteoporosis in patients requiring prolonged glucocorticoid therapy and for men with osteoporosis. Nasal or parenteral calcitonin is a first-line treatment for pain associated with acute vertebral fractures. Impact-type exercise and age-appropriate calcium and vitamin D intake are recommended for the prevention of osteoporosis. Validation: All recommendations were graded according to the strength of the evidence; where the evidence was insufficient and recommendations were based on consensus opinion alone, this is indicated. These guidelines are viewed as a work in progress and will be updated periodically in response to advances in this field.
Guidelines by Clinical Area · Fertility and Infertility Guidelines
Foresta C et al., 2002·European journal of human genetics : EJHG
Research on genetic causes of male and female infertility rapidly expanded in the last years, following the development of in vitro fertilising techniques. Genetic tests are now available to explore the cause of the infertility and assess the risk of a given couple to transmit its genetic characteristics. This allows at-risk couples to take an informed decision when electing for a medically assisted reproduction. It also allows the professionals to offer a prenatal diagnosis when appropriate. Thus, the genetic work-up of the infertile couple has become good practice for an appropriate diagnosis, treatment and prognostic assessment. The lack of national or international rules for the genetic approach to the infertile couple, prompted the Italian community of professionals in the field of reproductive medicine to join and set up guidelines for the genetic diagnosis of male and female infertility. The group of clinical and research experts is representative of 12 national scientific societies and was supported by external experts from four international societies. We examine the clinically relevant genetic causes of male and female infertility and suggest the category of patients for which each genetic test is recommended or optional, both for an accurate diagnosis and prior to ART.
Guideline Appraisal · Adoption and Practice Variation
To evaluate the appropriateness of recommendations for hysterectomies done for nonemergency and non-oncologic indications. We assessed the appropriateness of recommendations for hysterectomy for 497 women who had the operation between August 1993 and July 1995 in one of nine capitated medical groups in Southern California. Appropriateness was assessed using two sets of criteria, the first developed by a multispecialty expert physician panel using the RAND/University of California-Los Angeles appropriateness method, and the second consisting of the ACOG criteria sets for hysterectomies. The main outcome measure was the appropriateness of recommendation for hysterectomy, based on expert panel ratings and ACOG criteria sets. The most common indications for hysterectomy were leiomyomata (60% of hysterectomies), pelvic relaxation (11%), pain (9%), and bleeding (8%). Three hundred sixty-seven (70%) of the hysterectomies did not meet the level of care recommended by the expert panel and were judged to be recommended inappropriately. ACOG criteria sets were applicable to 71 women, and 54 (76%) did not meet ACOG criteria for hysterectomy. The most common reasons recommendations for hysterectomies considered inappropriate were lack of adequate diagnostic evaluation and failure to try alternative treatments before hysterectomy. Hysterectomy is often recommended for indications judged inappropriate. Patients and physicians should work together to ensure that proper diagnostic evaluation has been done and appropriate treatments considered before hysterectomy is recommended.
Diagnostic Criteria and Classification · Staging and Classification Systems
To examine exercise as a therapy for people with osteoporosis. Options: Immobilization, standing low-load and high-load physical activities. Outcomes: Risk of injury, quality of life, risk of falls and fractures, strength and posture and pain management. Evidence: Relevant epidemiologic studies, clinical trials and reviews were examined, including the large-scale FICSIT trial in the United States, a prospective 4-year study of women enrolled in an exercise program in Toronto and the large-scale Study of Osteoporotic Fractures. Values: Minimizing risk of injury and increasing quality of life were given a high value. BENEFITS, HARMS, And Costs: Moderate physical activity in people with osteoporosis can reduce the risk of falls and fractures, decrease pain and improve fitness and overall quality of life. It may also stimulate bone gain and decrease bone loss. Its positive effects are an adjunct to other interventions, such as hormonal therapy. It may give patients the confidence to resume regular activity and can provide social interaction and support. During exercise programs, proper nutrition is necessary to prevent excessive weight loss and impaired immune function resulting from inadequate protein, vitamin and mineral intake. Recommendations: Immobilization should be avoided if possible in anyone with osteoporosis or at increased risk for osteoporosis. Regular, moderate physical activity is recommended for those with osteoporosis. Elderly people should be assessed for risk of falling to identify those in greatest need of an exercise program. Community group exercise programs are beneficial. Younger people with osteoporosis also need exercise that will preserve or improve bone mass, muscular strength, endurance and cardiovascular fitness. Weight loss as a result of physical activity should be avoided and adequate intake of protein, vitamins and minerals assured. Because the benefits of physical activity are independent of the effect of other therapies, physical activity is an essential adjunct to appropriate nutrition and other therapies. Validation: These recommendations were developed by the Scientific Advisory Board of the Osteoporosis Society of Canada at its 1995 Consensus Conference. They are in agreement with the position taken on osteoporosis and exercise by the United States Center for Disease Control and Prevention and the American College of Sports Medicine. Sponsors: Sponsors of the 1995 conference included the Dairy Farmers of Canada, Eli Lilly Canada, Inc., Hoffmann-La Roche Canada Ltd., Merck Frosst Canada Inc. and Procter & Gamble Pharmaceuticals Canada Inc.
Diagnostic Criteria and Classification · Staging and Classification Systems
Parnell T et al., 2026·Journal of Restorative Reproductive Medicine·Free to read
To evaluate adherence to published American Society for Reproductive Medicine (ASRM) and American Urological Association (AUA) infertility evaluation and treatment recommendations among commercially insured infertility patients who subsequently underwent in vitro fertilization (IVF), and to assess whether observed care gaps support the need for a restorative reproductive medical framework.
A retrospective claims-based analysis was performed using MarketScan® Commercial Claims and Encounter Data between January 1, 2021, and December 31, 2024. Approximately five million commercially insured members were evaluated. Patients with infertility-related diagnoses who subsequently underwent IVF were identified. Claims were analyzed for evidence of selected diagnostic testing, medical treatment, or surgical interventions recommended by ASRM or AUA/ASRM guidance for specific infertility-related diagnoses before IVF initiation. Cumulative adherence rates were assessed up to nine months following initial infertility diagnosis and compared with the timing of initiating IVF.
IVF initiation started early and consistently preceded completion of most recommended evaluations and treatments. By 3 months, the proportion of patients with IVF initiation ranged from 28% to 39% across different infertility-related diagnoses, while adherence to most recommended interventions remained low. Overall, by 9 months, IVF utilization had reached 70–85%, while many recommended evaluations and treatments remained below 40% adherence, with several interventions remaining below 15%. Observed care gaps (percentage of patients receiving IVF prior to other evaluation or treatment recommendations) ranged from approximately 13% to 78% for most recommended evaluations and treatments, with several measures demonstrating gaps over 50% of patients.
These findings suggest substantial divergence between published infertility-care recommendations and observed practice patterns. From the perspective of restorative reproductive medicine (RRM), the gaps are clinically important because many recommended steps are directed toward identifying, correcting, restoring, or preserving reproductive function and anatomy before offering or initiating IVF treatment. Limitations to these data include lack of individualized patient medical data, preferences, or circumstances, and not capturing any treatment that was not reimbursed by commercial insurance (i.e., any cash payment for services). In addition, the recommendations assessed have variable levels of underlying evidence, and likely vary in the level of their acceptance among practicing clinicians.
Many commercially insured infertility patients progressed to IVF without documented evidence of diagnostic evaluation or therapeutic interventions recommended in ASRM and AUA/ASRM guidance. These findings raise important questions regarding the implementation of adequate evaluation before IVF and the extent to which patients receive meaningful opportunities for diagnosis-directed treatment of potentially reversible causes of infertility. The findings further suggest an important role for RRM as a quality-of-care framework focused on comprehensive evaluation, correction of underlying dysfunction, preservation of reproductive anatomy and physiology, and optimization of patient-centered fertility care, prior to considering IVF.
Grande G et al., 2026·The Journal of clinical endocrinology and metabolism·Free to read
Male factor infertility (MFI) is frequently labelled idiopathic when evaluation relies primarily on semen analysis, potentially overlooking endocrine and pathophysiological mechanisms relevant for targeted management.
To phenotypically define MFI and develop a pathophysiology-based classification aimed at reducing idiopathic infertility following comprehensive evaluation.
Prospective monocentric cohort study conducted at a tertiary referral academic centre.
Eight hundred male partners of infertile couples evaluated between October 2024 and January 2026 after exclusion of isolated female factor infertility.
Prevalence of MFI categories, hormonal patterns across phenotypes, and proportion of idiopathic infertility after comprehensive work-up.
All patients underwent standardized clinical evaluation, hormonal assessment (total testosterone, FSH, LH), testicular ultrasound, and complete semen analysis. Microbiological testing, transrectal ultrasound, and genetic analyses were performed according to guidelines.
Primary spermatogenic failure was the most prevalent category (56.0%), followed by infection/inflammation (22.4%) and hypogonadotropic hypogonadism (8.5%). Idiopathic infertility was identified in only 5.3% of cases. Distinct endocrine profiles were observed, with high-FSH spermatogenic failure representing the dominant phenotype.
Comprehensive phenotyping markedly reduces the proportion of patients classified as having idiopathic infertility and identifies clinically relevant subgroups. This prospective study provides validation of a pathophysiology-based classification and supports a shift toward endocrine-integrated diagnostic strategies in male infertility, with potential implications for targeted management.
Yong PJ et al., 2026·Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC
To provide health care professionals with an evidence-based approach to the management of endometriosis and its associated symptoms.
Women and gender-diverse individuals affected by endometriosis.
BENEFITS, HARMS, Timely and effective management of endometriosis has the potential to reduce pain, improve fertility and quality of life, and enhance long-term health outcomes. Early intervention may also help mitigate the financial and health system burdens associated with delayed diagnosis and treatment.
Published literature was retrieved through searches of PubMed, Ovid, Medline, Embase, Scopus, and the Cochrane Library from August 2010 through December 2025, using relevant MeSH heading and keywords. Results were restricted to systematic reviews, meta-analyses, randomized controlled trials/controlled clinical trials, observational studies, and clinical practice guidelines. Results were limited to English or French language materials. Evidence was supplemented with references from the 2010 Society of Obstetricians and Gynaecologists of Canada guideline No. 244.
The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional recommendations).
Health care providers involved in the care of individuals with endometriosis.
Early identification and management of endometriosis can significantly improve patient outcomes, reduce long-term health care costs and improve their quality of life.
RECOMMENDATIONS.
Manhart MD et al., 2025·Linacre Q·Free full text on PubMed Central
A one-day meeting was held as a pre-conference to the Catholic Medical Association Annual Educational event in 2024. A panel of eighteen physicians, scientists, and researchers involved in NFP work was convened to review the available evidence in four topical areas: (i) evidence for effectiveness of NFP methods to postpone and achieve pregnancy, (ii) evidence for effectiveness in the postpartum and perimenopause transition periods, (iii) evaluate the current state of technology in NFP (specifically app and quantitative hormone monitoring), and (iv) evidence examining the impact of NFP on marital relations. In each topical area, the panel worked to reach a consensus opinion on the currently available evidence and identified priorities for further research. Results from these discussions and a set of priorities for further work are presented here.
An expert panel was convened to review the current evidence supporting use of NFP in various settings, utilization of new technology, and the impact of NFP on marital dynamics. Results from these discussions and a set of priorities for further work are presented here.
Policy and Regulation · Access and Coverage Policy
Despite high incidence of endometriosis internationally and domestically, many patients wait a decade after symptom onset for an accurate diagnosis. This article suggests why diagnostic criteria should be clarified and why endometriosis screening should be incentivized among members of the public, clinicians, and health care organizations.
Abstract
The general point of view on disclosure of the donor conception to the offspring experienced a major change over the years. From the outset, non-disclosure was imposed by medical professionals. Decades of debates followed, discussing if disclosure or non-disclosure would be in the best interest of the donor-conceived person, before the recommendation to disclose the donor conception to the offspring was integrated in professional guidelines such as those of ASRM (2013) and ESHRE (2024). This change in view was supported by research findings showing that late disclosure (and often discovery) has a negative impact on the wellbeing of donor-conceived people, that early disclosure is not burdensome for donor-conceived children (moreover, it is preferred by donor-conceived people), and that early disclosure is associated with better well-being of donor-conceived people during adolescence. Moreover, societal changes, such as the technological development of direct-to-consumer-genetic testing, have made non-disclosure impossible. Lastly, the framing of disclosure as a question concerning ‘the best interest’ of donor-conceived people has been replaced by a framework that information about one’s origin concerns a fundamental human right.
Not only did the recommendation regarding disclosure/non-disclosure changed, also the knowledge about disclosure increased. While initially disclosure was often approached as a dichotomous act, research findings showed that disclosure occurs much more in layers. Moreover, disclosure is not a one-off activity, but (as preferred by donor-conceived people themselves) an ongoing conversation over the family-life course, that continues when the child grows up. Besides, disclosure is not a unilateral process in which only parents take up an active role, but it is an interactive process in which parent and child co-create their family-story. Lastly, disclosure does not only concern the origins of the child, but it is also a family-building story, in which parents formed their family in a different way they initially imagined.
In relation to the actual disclosure process, studies have shown that parental confidence is generally associated with disclosure and a lack of confidence (including uncertainty around the language to use, the best way and time to disclose, and finding the information difficult to share) is associated with non-disclosure. A recent literature review showed that many participants across studies reported feelings of being unprepared, isolation and anxiety around the disclosure decision and process, and express a desire for support. Parents would like to hear experiences from other parents and to have access to resources, such as storybooks and movies, and networking opportunities for the donor-conceived people as they might enhance feeling comfortable with the disclosure process. However, support and advice were not always provided.
This presentation reviews the latest existing empirical data regarding the disclosure-process (factors that might influence the process, outcomes, experiences of parents and donor-conceived people) and will especially address how, psychosocial as well as medical, professionals can support families in their ongoing conversation about their family-building, pre-, during and post-treatment. Furthermore, challenges and limitations of offering ongoing support will be discussed as well, based on an inquiry conducted in 10 jurisdictions.
Human Fertilisation and Embryology Authority, 2024
The HFEA Code of Practice gives guidance to clinics about the proper conduct of activities licensed under the Human Fertilisation and Embryology Act 1990 (as amended). The 9th edition (effective 26 October 2023) was further amended for version 9.4 (effective 1 October 2024). The Code consolidates statutory regulations, license conditions, and HFEA guidance covering: clinic governance, staff training and qualifications, identity checks and consent, gamete and embryo storage, donor recruitment and screening, donation arrangements, treatment licensing, pre-implantation genetic testing, multiple births policy, surrogacy, witnessing procedures, traceability, adverse incidents reporting, complaints, research licensing, and information disclosure. Compliance with the Code is a statutory requirement for all UK clinics licensed by the HFEA. Version 9.4 includes updated guidance on donor compensation (effective October 2024) and known donation for people with undetectable HIV (effective November 2024).
Raperport C et al., 2024·BJOG : an international journal of obstetrics and gynaecology·Free to read
There is no consensus on tests required to either diagnose unexplained infertility or use for research inclusion criteria. This leads to heterogeneity and bias affecting meta-analysis and best practice advice. This systematic review analyses the variability of inclusion criteria applied to couples with unexplained infertility. We propose standardised criteria for use both in future research studies and clinical diagnosis. CINAHL and MEDLINE online databases were searched up to November 2022 for all published studies recruiting couples with unexplained infertility, available in full text in the English language. Data were collected in an Excel spreadsheet. Results were analysed per category and methodology or reference range. Of 375 relevant studies, only 258 defined their inclusion criteria. The most commonly applied inclusion criteria were semen analysis, tubal patency and assessment of ovulation in 220 (85%), 232 (90%), 205 (79.5%) respectively. Only 87/220 (39.5%) studies reporting semen analysis used the World Health Organization (WHO) limits. Tubal patency was accepted if bilateral in 145/232 (62.5%) and if unilateral in 24/232 (10.3%). Ovulation was assessed using mid-luteal serum progesterone in 115/205 (56.1%) and by a history of regular cycles in 87/205 (42.4%). Other criteria, including uterine cavity assessment and hormone profile, were applied in less than 50% of included studies. This review highlights the heterogeneity among studied populations with unexplained infertility. Development and application of internationally accepted criteria will improve the quality of research and future clinical care.
Male Endocrine and Genetic Factors · Genetic Causes of Male Infertility
Graziani A et al., 2024·Genes·Free full text on PubMed Central
Several genes are implicated in spermatogenesis and fertility regulation, and these genes are presently being analysed in clinical practice due to their involvement in male factor infertility (MFI). However, there are still few genetic analyses that are currently recommended for use in clinical practice. In this manuscript, we reviewed the genetic causes of qualitative sperm defects. We distinguished between alterations causing reduced sperm motility (asthenozoospermia) and alterations causing changes in the typical morphology of sperm (teratozoospermia). In detail, the genetic causes of reduced sperm motility may be found in the alteration of genes associated with sperm mitochondrial DNA, mitochondrial proteins, ion transport and channels, and flagellar proteins. On the other hand, the genetic causes of changes in typical sperm morphology are related to conditions with a strong genetic basis, such as macrozoospermia, globozoospermia, and acephalic spermatozoa syndrome. We tried to distinguish alterations approved for routine clinical application from those still unsupported by adequate clinical studies. The most important aspect of the study was related to the correct identification of subjects to be tested and the correct application of genetic tests based on clear clinical data. The correct application of available genetic tests in a scenario where reduced sperm motility and changes in sperm morphology have been observed enables the delivery of a defined diagnosis and plays an important role in clinical decision-making. Finally, clarifying the genetic causes of MFI might, in future, contribute to reducing the proportion of so-called idiopathic MFI, which might indeed be defined as a subtype of MFI whose cause has not yet been revealed.
Lin T et al., 2024·Fertility and sterility·Free to read
The World Endometriosis Research Foundation established the Endometriosis Phenome and Biobanking Harmonisation Project (EPHect) to create standardized documentation tools (with common data elements) to facilitate the comparison and combination of data across different research sites and studies. In 2014, 4 data research standards were published: clinician-reported surgical data, patient-reported clinical data, and fluid and tissue biospecimen collection. Our current objective is to create an EPHect standard for the clinician-reported physical examination (EPHect-PE) for research studies.
An international consortium involving 26 clinical and academic experts and patient partners from 11 countries representing 25 institutions and organizations. Two virtual workshops, followed by the development of the physical examination standards underwent multiple rounds of iterations and revisions.
N/A MAIN OUTCOME MEASURE(S): N/A RESULT(S): The EPHect-PE tool provides standardized assessment of physical examination characteristics and pain phenotyping. Data elements involve examination of back and pelvic girdle; abdomen including allodynia and trigger points; vulva including provoked vestibulodynia; pelvic floor muscle tone and tenderness; tenderness on unidigital pelvic examination; presence of pelvic nodularity; uterine size and mobility; presence of adnexal masses; presence of incisional masses; speculum examination; tenderness and allodynia at an extra-pelvic site (e.g., forearm); and recording of anthropometrics.
CONCLUSION(S): The EPHect-PE standards will facilitate the standardized documentation of the physical examination, including the assessment and documentation of examination phenotyping of endometriosis-associated pelvic pain.
Weingarten SJ et al., 2024·Focus (American Psychiatric Publishing)·Free full text on PubMed Central
Perinatal mood and anxiety disorders (PMADs) are the most common complication of childbirth. When poorly controlled, they are associated with worse obstetric outcomes, such as higher rates of preterm birth and unplanned cesarean delivery. They are also associated with suicide, a leading cause of perinatal maternal death. This article provides an overview of evidence-based recommendations for screening, assessment, and management of PMADs, including suicide risk assessment and management and pharmacological and nonpharmacological treatment options compatible with pregnancy and lactation. Although specialized reproductive psychiatrists can provide expert guidance for the management of PMADs, their scarcity means that most patients will not have access to this expert care and instead will seek guidance from general psychiatrists. This article provides a clinical guide for generalists that is based on the best current evidence, including recently released treatment guidelines.
Allaire C et al., 2024·Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC
To provide evidence-based recommendations for the management of chronic pelvic pain in females.
This guideline is specific to pelvic pain in adolescent and adult females and excluded literature that looked at pelvic pain in males. It also did not address genital pain.
BENEFITS, HARMS, The intent is to benefit patients with chronic pelvic pain by providing an evidence-based approach to management. Access to certain interventions such as physiotherapy and psychological treatments, and to interdisciplinary care overall, may be limited by costs and service availability.
Medline and the Cochrane Database from 1990 to 2020 were searched for articles in English on subjects related to chronic pelvic pain, including diagnosis, overlapping pain conditions, central sensitization, management, medications, surgery, physiotherapy, psychological therapies, alternative and complementary therapies, and multidisciplinary and interdisciplinary care. The committee reviewed the literature and available data and used a consensus approach to develop recommendations. Only articles in English and pertaining to female subjects were included.
The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional [weak] recommendations).
Family physicians, gynaecologists, urologists, pain specialists, physiotherapists, and mental health professionals.
Management of chronic pelvic pain should consider multifactorial contributors, including underlying central sensitization/nociplastic pain, and employ an interdisciplinary biopsychosocial approach that includes pain education, physiotherapy, and psychological & medical treatments.
RECOMMENDATIONS.
The purpose of this article is to provide an explanation of the background behind a checklist that declares the laboratory methods used in a scientific study. It focuses primarily on implementing laboratory procedures to yield reliable results in basic semen examinations. While the World Health Organization (WHO) and international standards provide recommendations for basic semen examination, manuscripts submitted to Andrology frequently lack transparency regarding the specific techniques used. In addition, the terminology used for semen examination results often fails to provide a clear definition of the groups under study. Furthermore, the WHO's reference limits are often misinterpreted as strict boundaries between fertility and infertility. It is important to note that valid clinical andrological diagnoses and treatments cannot rely solely on semen examination results; they require proper laboratory procedures as a foundation for diagnosing and treating male patients. Therefore, scientific journals should promote the adoption of robust laboratory practices and an accurate definition of patient groups. A checklist can facilitate the design of high-quality studies and the creation of informative publications. Further, it can help journals assess submitted manuscripts and improve the overall quality of their publications.
Neural tube defects are among the most common congenital malformations in the US, with an estimated 3000 pregnancies affected each year. Many of these neural tube defects are caused by low folate levels in the body. The US Preventive Services Task Force (USPSTF) commissioned a reaffirmation evidence update on the benefits and harms of folic acid supplementation. Population: Persons who are planning to or could become pregnant.Evidence Assessment The USPSTF concludes that, for persons who are planning to or could become pregnant, there is high certainty that folic acid supplementation has a substantial net benefit to prevent neural tube defects in their offspring.Recommendation The USPSTF recommends that all persons planning to or who could become pregnant take a daily supplement containing 0.4 to 0.8 mg (400 to 800 μg) of folic acid. (A recommendation)
Ethics Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org, 2023·Fertility and sterility
Building families through the adoption of children has been supported by human society throughout history. The ethical appropriateness of patients donating embryos to other patients for family building, or for research, is well established and is affirmed by this Committee. The use of the term ''adoption'' for embryos is inaccurate and should be avoided. This document replaces the ASRM Ethics Committee statement by the same name, last published in 2016.
Klein Meuleman SJM et al., 2023·JAMA Netw Open·Free full text on PubMed Central
Approximately 60% of women develop a uterine niche after a cesarean delivery (CD). A niche is associated with various gynecological symptoms including abnormal uterine bleeding, pain, and infertility, but there is little consensus in the literature on the distinction between the sonographic finding of a niche and the constellation of associated symptoms. To achieve consensus on defining the clinical condition that constitutes a symptomatic uterine niche and agree upon diagnostic criteria and uniform nomenclature for this condition.
Design, Setting, and A consensus based modified electronic Delphi (eDelphi) study, with a predefined Rate of Agreement (RoA) of 70% or higher. Experts were selected according to their expertise with niche-related consultations, publications, and participation in expert groups and received online questionnaires between November 2021 and May 2022. Definition, nomenclature, symptoms, conditions to exclude, and diagnostic criteria of an illness caused by a symptomatic uterine niche. In total, 31 of the 60 invited experts (51.7%) participated, of whom the majority worked in university-affiliated hospitals (28 of 31 [90.3%]), specialized in benign gynecology (20 of 31 [64.5%]), and worked in Europe (24 of 31 [77.4%]). Three rounds were required to achieve consensus on all items. All participants underlined the relevance of a new term for a condition caused by a symptomatic niche and its differentiation from a sonographic finding only. Experts agreed to name this condition cesarean scar disorder, defined as a uterine niche in combination with at least 1 primary or 2 secondary symptoms (RoA, 77.8%). Defined primary symptoms were postmenstrual spotting, pain during uterine bleeding, technical issues with catheter insertion during embryo transfer, and secondary unexplained infertility combined with intrauterine fluid. Secondary symptoms were dyspareunia, abnormal vaginal discharge, chronic pelvic pain, avoiding sexual intercourse, odor associated with abnormal blood loss, secondary unexplained infertility, secondary infertility despite assisted reproductive technology, negative self-image, and discomfort during participation in leisure activities. Consensus was also achieved on certain criteria that should be met and conditions that should be excluded before making the diagnosis. Conclusions and Relevance: In this modified Delphi study, a panel of 31 international niche experts reached consensus for the constellation of symptoms secondary to a uterine niche and named it cesarean scar disorder.
Hariton E et al., 2023·Fertility and Sterility·Free to read
The field of reproductive endocrinology and infertility (REI) is at a crossroads; there is a mismatch between demand for reproductive endocrinology, infertility and assisted reproductive technology (ART) services, and availability of care. This document's focus is to provide data justifying the critical need for increased provision of fertility services in the United States now and into the future, offer approaches to rectify the developing physician shortage problem, and suggest a framework for the discussion on how to meet that increase in demand. The Society of REI recommend the following: 1. Our field should aggressively explore and implement courses of action to increase the number of qualified, highly trained REI physicians trained annually. We recommend efforts to increase the number of REI fellowships and the size complement of existing fellowships be prioritized where possible. These courses of action include: a. Increase the number of REI fellowship training programs. b. Increase the number of fellows trained at current REI fellowship programs. c. The pros and cons of a 2-year focused clinical fellowship track for fellows interested primarily in ART practice were extensively explored. We do not recommend shortening the REI fellowship to 2 years at this time, because efforts should be focused on increasing the number of fellowship training slots (1a and b). 2. It is recommended that the field aggressively implements courses of action to increase the number of and appropriate usage of non-REI providers to increase clinical efficiency under appropriate board-certified REI physician supervision. 3. Automating processes through technologic improvements can free providers at all levels to practice at the top of their license.
van Bommel MHD et al., 2022·Hum Reprod Update·Free full text on PubMed Central
Increasing numbers of BReast CAncer (BRCA) 1 or 2 pathogenic variant (PV) carriers, who have an inherited predisposition to breast and ovarian cancer, are being identified. Among these women, data regarding the effects of contraception on cancer risks are unclear and various guidelines provide various recommendations. We aim to optimize counselling regarding contraception for BRCA1/2-PV carriers. Therefore, we performed a systematic review and meta-analysis. We investigated the risk ratio for developing breast cancer or ovarian cancer in BRCA1/2-PV carriers who have used any form of contraception versus non-users. Second, we analysed breast and ovarian cancer risk among BRCA1/2-PV carriers as influenced by the duration of contraceptive use and by the time since last use. In addition, we provide an overview of all relevant international guidelines regarding contraceptive use for BRCA1/2-PV carriers. A systematic search in the Medline database and Cochrane library identified studies describing breast and/or ovarian cancer risk in BRCA1/2-PV carriers as modified by contraception until June 2021. The search included medical subject headings, keywords and synonyms related to BRCA and contraceptives (any kind). PRISMA guidance was followed. Risk Of Bias In Non-randomized Studies of Interventions and Grading of Recommendations, Assessment, Development and Evaluations assessments were performed. Random-effects meta-analyses were used to estimate pooled effects for breast and ovarian cancer risk separately. Subgroup analyses were conducted for BRCA1 versus BRCA2 and for the various contraceptive methods. Outcomes: Results of the breast cancer risk with oral contraceptive pill (OCP) analysis depended on the outcome measure. Meta-analyses of seven studies with 7525 women revealed a hazard ratio (HR) of 1.55 (95% CI: 1.36-1.76) and of four studies including 9106 women resulted in an odds ratio (OR) of 1.06 (95% CI: 0.90-1.25), heterogeneity (I2) 0% and 52%, respectively. Breast cancer risk was still increased in ever-users compared with never-users >10 years after last OCP use. In contrast, ovarian cancer risk was decreased among OCP users: HR 0.62 (95% CI: 0.52-0.74) based on two studies including 10 981 women (I2: 0%), and OR 0.49 (95% CI: 0.38-0.63) based on eight studies including 10 390 women (I2: 64%). The protective effect vanished after cessation of use. Tubal ligation also protects against ovarian cancer: one study including 3319 women (I2: 0%): HR: 0.44 (95% CI: 0.26-0.74) and three studies with 7691 women (I2: 44%): OR: 0.74 (95% CI: 0.53-1.03). Data regarding other contraceptives were unavailable. No differences were observed between BRCA1 and BRCA2-PV carriers. The quality of evidence was either low or very low. The OCP potentially increases breast cancer risk, while ovarian cancer risk decreases with either the OCP and tubal ligation in BRCA1/2-PV carriers. Counselling of BRCA1/2-PV carriers should be personalized; the genetic and non-genetic factors (like prior risk-reducing surgeries, prior breast cancer and age) and patients' preferences (reversibility, ease of use, reliability and effect on menstrual cycle) should be balanced. To further optimize counselling for high-risk women, future research should focus on other (commonly used) contraceptive methods and cancer risks in this specific population, and on the potential impact of changing formulations over time.
Tessema GA et al., 2022·PLoS medicine·Free full text on PubMed Central
The World Health Organization recommends to wait at least 6 months after miscarriage and induced abortion before becoming pregnant again to avoid complications in the next pregnancy, although the evidence-based underlying this recommendation is scarce. We aimed to investigate the risk of adverse pregnancy outcomes-preterm birth (PTB), spontaneous PTB, small for gestational age (SGA) birth, large for gestational age (LGA) birth, preeclampsia, and gestational diabetes mellitus (GDM)-by interpregnancy interval (IPI) for births following a previous miscarriage or induced abortion. We conducted a cohort study using a total of 49,058 births following a previous miscarriage and 23,707 births following a previous induced abortion in Norway between 2008 and 2016. We modeled the relationship between IPI and 6 adverse pregnancy outcomes separately for births after miscarriages and births after induced abortions. We used log-binomial regression to estimate unadjusted and adjusted relative risk (aRR) and 95% confidence intervals (CIs). In the adjusted model, we included maternal age, gravidity, and year of birth measured at the time of the index (after interval) births. In a sensitivity analysis, we further adjusted for smoking during pregnancy and prepregnancy body mass index. Compared to births with an IPI of 6 to 11 months after miscarriages (10.1%), there were lower risks of SGA births among births with an IPI of <3 months (8.6%) (aRR 0.85, 95% CI: 0.79, 0.92, p < 0.01) and 3 to 5 months (9.0%) (aRR 0.90, 95% CI: 0.83, 0.97, p = 0.01). An IPI of <3 months after a miscarriage (3.3%) was also associated with lower risk of GDM (aRR 0.84, 95% CI: 0.75, 0.96, p = 0.01) as compared to an IPI of 6 to 11 months (4.5%). For births following an induced abortion, an IPI <3 months (11.5%) was associated with a nonsignificant but increased risk of SGA (aRR 1.16, 95% CI: 0.99, 1.36, p = 0.07) as compared to an IPI of 6 to 11 months (10.0%), while the risk of LGA was lower among those with an IPI 3 to 5 months (8.0%) (aRR 0.84, 95% CI: 0.72, 0.98, p = 0.03) compared to an IPI of 6 to 11 months (9.4%). There was no observed association between adverse pregnancy outcomes with an IPI >12 months after either a miscarriage or induced abortion (p > 0.05), with the exception of an increased risk of GDM among women with an IPI of 12 to 17 months (5.8%) (aRR 1.20, 95% CI: 1.02, 1.40, p = 0.02), 18 to 23 months (6.2%) (aRR 1.24, 95% CI: 1.02, 1.50, p = 0.03), and ≥24 months (6.4%) (aRR 1.14, 95% CI: 0.97, 1.34, p = 0.10) compared to an IPI of 6 to 11 months (4.5%) after a miscarriage. Inherent to retrospective registry-based studies, we did not have information on potential confounders such as pregnancy intention and health-seeking bahaviour. Furthermore, we only had information on miscarriages that resulted in contact with the healthcare system. Our study suggests that conceiving within 3 months after a miscarriage or an induced abortion is not associated with increased risks of adverse pregnancy outcomes. In combination with previous research, these results suggest that women could attempt pregnancy soon after a previous miscarriage or induced abortion without increasing perinatal health risks.
Marshall NE et al., 2022·American journal of obstetrics and gynecology·Free full text on PubMed Central
Most women in the United States do not meet the recommendations for healthful nutrition and weight before and during pregnancy. Women and providers often ask what a healthy diet for a pregnant woman should look like. The message should be "eat better, not more." This can be achieved by basing diet on a variety of nutrient-dense, whole foods, including fruits, vegetables, legumes, whole grains, healthy fats with omega-3 fatty acids that include nuts and seeds, and fish, in place of poorer quality highly processed foods. Such a diet embodies nutritional density and is less likely to be accompanied by excessive energy intake than the standard American diet consisting of increased intakes of processed foods, fatty red meat, and sweetened foods and beverages. Women who report "prudent" or "health-conscious" eating patterns before and/or during pregnancy may have fewer pregnancy complications and adverse child health outcomes. Comprehensive nutritional supplementation (multiple micronutrients plus balanced protein energy) among women with inadequate nutrition has been associated with improved birth outcomes, including decreased rates of low birthweight. A diet that severely restricts any macronutrient class should be avoided, specifically the ketogenic diet that lacks carbohydrates, the Paleo diet because of dairy restriction, and any diet characterized by excess saturated fats. User-friendly tools to facilitate a quick evaluation of dietary patterns with clear guidance on how to address dietary inadequacies and embedded support from trained healthcare providers are urgently needed. Recent evidence has shown that although excessive gestational weight gain predicts adverse perinatal outcomes among women with normal weight, the degree of prepregnancy obesity predicts adverse perinatal outcomes to a greater degree than gestational weight gain among women with obesity. Furthermore, low body mass index and insufficient gestational weight gain are associated with poor perinatal outcomes. Observational data have shown that first-trimester gain is the strongest predictor of adverse outcomes. Interventions beginning in early pregnancy or preconception are needed to prevent downstream complications for mothers and their children. For neonates, human milk provides personalized nutrition and is associated with short- and long-term health benefits for infants and mothers. Eating a healthy diet is a way for lactating mothers to support optimal health for themselves and their infants.
Wang N et al., 2022·Front Physiol·Free full text on PubMed Central
To establish a system for evaluation of semen quality in fertile men by factor analysis (FA). The FA method was used to analyze five sperm test indicators for fertile men (sperm pH, sperm motility, sperm progressive motility, semen density, and total sperm number) to determine the evaluation standard of semen quality. Pearson analysis was adopted for correlation testing. The comprehensive score formula for semen quality of normal fertile men was as follows: comprehensive score of semen quality = (0.38272 F(1) + 0.36359 F(2) + 0.20018 F (3))/94.699. Across the whole fertile population, semen quality was found to be correlated with abstinence period, age of first spermatorrhea, and frequency of intercourse. Smoking, drinking, and place of residence were correlated with semen quality in the high semen quality population. In the population with medium semen quality, only the abstinence period was associated with semen quality. It is feasible to evaluate the semen quality of fertile men using the FA method. The comprehensive indicators of semen volume, sperm motility, and semen pH can be used as evaluative measures. Across the whole fertile population, the abstinence period and age of first spermatorrhea were correlated with semen quality. In the high semen quality population, smoking and drinking were negatively correlated with semen quality, and participants living in rural areas had better semen quality.
Ferlin A et al., 2022·Journal of endocrinological investigation
Infertility affects 15-20% of couples and male factors are present in about half of the cases. For many aspects related to the diagnostic and therapeutic approach of male factor infertility, there is no general consensus, and the clinical approach is not uniform.
In the present document by the Italian Society of Andrology and Sexual Medicine (SIAMS), endorsed by the Italian Society of Embryology, Reproduction, and Research (SIERR), we propose evidence-based recommendations for the diagnosis, treatment, and management of male factor infertility to improve patient and couple care.
Components of the initial evaluation should include at minimum medical history, physical examination, and semen analysis. Semen microbiological examination, endocrine assessment, and imaging are suggested in most men and recommended when specific risk factors for infertility exist or first-step analyses showed abnormalities. Full examination including genetic tests, testicular cytology/histology, or additional tests on sperm is clinically oriented and based on the results of previous investigations. For treatment purposes, the identification of the specific cause and the pathogenetic mechanism is advisable. At least, distinguishing pre-testicular, testicular, and post-testicular forms is essential. Treatment should be couple-oriented, including lifestyle modifications, etiologic therapies, empirical treatments, and ART on the basis of best evidence and with a gradual approach.
These Guidelines are based on two principal aspects: they are couple-oriented and place high value in assessing, preventing, and treating risk factors for infertility. These Guidelines also highlighted that male infertility and in particular testicular function might be a mirror of general health of a man.
Practice Committee of the American Society for Reproductive Medicine, 2021·Fertility and sterility
Diagnostic evaluation for infertility in women should be conducted in a systematic, expeditious, and cost-effective manner to identify all the relevant factors with an initial emphasis on the least invasive methods for detecting the most common causes of infertility. The purpose of this committee opinion is to provide a critical review of the current methods and procedures for the evaluation of in fertile women, and it replaces the document of the same name, last published in 2015 (Fertil Steril 2015;103:e44-50). This guidance is intended for any provider evaluating women for infertility.
Ethics Committee of the American Society for Reproductive Medicine, 2021·Fertility and sterility
This statement explores the implications of reproduction by single individuals and unmarried couples and pertains to diverse sexuality and gender (DSG) or cisgender heterosexual persons. The statement concludes that individuals and couples should have access to fertility services irrespective of marital status, sexual orientation, or gender identity. This document replaces the previous version of this document entitled "Access to fertility treatment by gays, lesbians, and unmarried persons: a committee opinion", published in December 2013 (Fertil Steril 2013;100:1524-7).
Turner JV, 2021·The journal of obstetrics and gynaecology research
Simplified contraceptive method-efficacy and/or typical-use effectiveness rates are commonly used for direct comparison of the various contraceptive methods. Use of such effectiveness rates in this manner is, however, problematic in relation to the fertility awareness methods (FAMs). The aim of this review is to critically examine current international representation of contraceptive effectiveness for the various FAMs in clinical use. This review also details important issues when appraising and interpreting studies on FAMs used for avoiding pregnancy. Current international literature regarding contraceptive effectiveness of FAMs was surveyed and appraised. This included World Health Organization and Centers for Disease Control (USA) resources, key clinical studies and recent systematic reviews. Chinese literature was also searched, since these data have not been reported in the English literature. Reliance on certain historical studies has led to the misrepresentation of contraceptive effectiveness of FAMs by perpetuation of inaccurate figures in clinical guidelines, the international literature and the public domain. Interpretation of published study results for FAMs is difficult due to variability in study methodology and other clinical trial quality issues. Recent systematic analyses have noted the considerable issues with study designs and limitations. Several non-English published studies using the Billings Ovulation Method have demonstrated that a broader review of the literature is required to better capture the data potentially available. A deeper understanding by clinicians and the public of the applicability of contraceptive effectiveness rates of the various FAMs is needed, instead of reliance on the inaccurate conglomerate figures that are widely presented.
Hoeger KM et al., 2021·The Journal of Clinical Endocrinology & Metabolism
Polycystic ovary syndrome (PCOS) is one of the most common reproductive endocrine disorders in women and despite this, diagnostic challenges, delayed diagnosis, and less-than-optimal treatment regimens plague the condition. The International PCOS network, consisting of geographically diverse international experts in PCOS as well as consumers, engaged in a multi-year international evidence-based guideline development process that was jointly sponsored by the European Society for Human Reproduction and Embryology (ESHRE) and the American Society of Reproductive Medicine (ASRM). The guideline was published in 2018 and endorsed by more than 40 international societies involved in PCOS. Translation of this evidence-based guideline to medical practice and consumer groups remains a priority. However, there remain many challenges to both understanding the diagnosis and treatment of PCOS. Evidence suggests that both clinicians and consumers are not satisfied with the timeliness of diagnosis and treatment options. This review summarizes the important findings for diagnosis and treatment from the guidelines and expands on recent developments in the literature since its publication. Special attention to diagnosis at the ends of the reproductive spectrum are discussed and remaining areas of controversy are noted. Additionally, the review highlights some of the remaining challenges in the understanding and management of PCOS to help guide clinicians and investigators in this perplexing condition.
Meeting the ethical obligations of informed consent requires that an obstetrician-gynecologist gives the patient adequate, accurate, and understandable information and requires that the patient has the ability to understand and reason through this information and is free to ask questions and to make an intentional and voluntary choice, which may include refusal of care or treatment. Shared decision making is a patient-centered, individualized approach to the informed consent process that involves discussion of the benefits and risks of available treatment options in the context of a patient's values and priorities. Some informed consent challenges are universal to medicine, whereas other challenges arise more commonly in the practice of obstetrics and gynecology than in other specialty areas. This Committee Opinion focuses on informed consent for adult patients in clinical practice and provides new guidance on the practical application of informed consent through shared decision making. The principles outlined in this Committee Opinion will help support the obstetrician-gynecologist in the patient-centered informed consent process.
Ethics Committee of the American Society for Reproductive Medicine, 2021·Fertility and sterility
Financial compensation of women donating oocytes for reproductive or research purposes is justified on ethical grounds and should acknowledge the time, inconvenience, and discomfort associated with screening, ovarian stimulation, oocyte retrieval, and postretrieval recovery and not vary according to the planned use of the oocytes or the number or quality of oocytes retrieved. This document replaces the document of the same name published in 2016.
Ethics Committee of the American Society for Reproductive Medicine, 2021·Fertility and sterility
Human Immunodeficiency Virus is a serious but manageable chronic disease that affects persons of reproductive age, many of whom express a desire for biological parenthood. This document is a revision of the original document of the same name, last published in 2015 (Fertil Steril 2015;104:e1-8).
Ethics Committee of the American Society for Reproductive Medicine, 2021·Fertility and sterility
Programs should create and enforce written policies addressing the designation, retention, and disposal of unclaimed embryos. In the absence of program-specific policies, it is ethically permissible for a program or facility to consider embryos to have been unclaimed if a reasonable period of time has passed since contact with an individual or couple; efforts as outlined in the consent form have been made to contact the individual or couple; and no written instructions from the individual or couple with dispositional control exist concerning disposition. In such cases, programs or facilities may dispose of unclaimed embryos by removing them from storage and thawing without transfer. In the absence of specific written instructions, unclaimed embryos may not be donated to others for reproductive use or be used in research. This statement replaces the American Society for Reproductive Medicine Ethics Committee document "Disposition of Abandoned Embryos" published in 2013.
Study purposeMorphometric methods categorize potential osteoporotic vertebral fractures (OVF) on the basis of loss of vertebral height. A particular example is the widely used semiquantitative morphometric tool proposed by Genant (GSQ). A newer morphologic algorithm-based qualitative (mABQ) tool focuses on vertebral end-plate damage in recognizing OVF. We used data from both sexes in the Canadian Multicentre Osteoporosis Study (CaMos) to compare the 2 methods in identifying OVF at baseline and during 10 years of follow-up. We obtained lateral thoracic and lumbar spinal radiographs (T4-L4) 3 times, at 5-year intervals, in 828 participants of the population-based CaMos. Logistic regressions were used to study the association of 10-year changes in bone mineral density (BMD) with incident fractures. At baseline, 161 participants had grade 1 and 32 had grade 2 GSQ OVF; over the next 10 years, only 9 of these participants had sustained incident GSQ OVF. Contrastingly, 21 participants at baseline had grade 1 and 48 grade 2 mABQ events; over the next 10 years, 79 subjects experienced incident grade 1 or grade 2 mABQ events. Thus, incident grades 1 and 2 morphologic fractures were 8 times more common than morphometric deformities alone. Each 10-year decrease of 0.01 g/cm2 in total hip BMD was associated with a 4.1% (95% CI: 0.7-7.3) higher odds of having an incident vertebral fracture. This analysis further suggests that morphometric deformities and morphologic fractures constitute distinct entities; morphologic fractures conform more closely to the expected epidemiology of OVF.
Garolla A et al., 2020·Front Endocrinol (Lausanne)·Free full text on PubMed Central
This expert opinion summarizes current knowledge on risk factors for infertility and identifies a practical clinical and diagnostic approach for the male and female partners of an infertile couple aimed to improve the investigation and management of fertility problems. Infertility represents an important and growing health problem affecting up to 16% of couples worldwide. In most cases, male, female, or combined factor can be identified, and different causes or risk factors have been related to this condition. However, there are no standardized guidelines on the clinical-diagnostic approach of infertile couples and the recommendations concerning infertility are sometimes lacking, incomplete, or problematic to apply. The aim of this work is to provide an appropriate clinical and diagnostic pathway for infertile couples designed by a multidisciplinary-team of experts. The rationale is based on the history and physical examination and then oriented on the basis of initial investigations. This approach could be applied in order to reduce variation in practice and to improve the investigation and management of fertility problems. Prominent Italian experts of the main specialties committed in the ART procedures, including gynecologists, andrologists, embryologists, biologists, geneticists, oncologists, and microbiologists, called "InfertilItaly group", used available evidence to develop this expert position. Starting from the individuation of the principal risk factors that may influence the fertility of females and males and both genders, the work group identified most appropriate procedures using a gradual approach to both partners aimed to obtain a precise diagnosis and the most effective therapeutic option, reducing invasive and occasionally redundant procedures. This expert position provides current knowledge on risk factors and suggests a diagnostic workflow of infertile couples. By using this step-by-step approach, health care workers involved in ART, may individuate a practical clinical management of infertile couples shared by experts.
Esteves SC et al., 2020·Andrologia·Free full text on PubMed Central
We herein summarise the evidence concerning the impact of sperm DNA fragmentation in various clinical infertility scenarios and the advances on sperm DNA fragmentation tests. The collected evidence was used to formulate 41 recommendations. Of these, 13 recommendations concern technical aspects of sperm DNA fragmentation testing, including pre-analytical information, clinical thresholds and interpretation of results. The remaining 28 recommendations relate to indications for sperm DNA fragmentation testing and clinical management. Clinical scenarios like varicocele, unexplained infertility, idiopathic infertility, recurrent pregnancy loss, intrauterine insemination, in vitro fertilisation/intracytoplasmic sperm injection, fertility counselling for men with infertility risk factors and sperm cryopreservation have been contemplated. The bulk evidence supporting the recommendations has increased in recent years, but it is still of moderate to low quality. This guideline provides clinicians with advice on best practices in sperm DNA fragmentation testing. Also, recommendations are provided on possible management strategies to overcome infertility related to sperm DNA fragmentation, based on the best available evidence. Lastly, we identified gaps in knowledge and opportunities for research and elaborated a list of recommendations to stimulate further investigation.
Aversa A et al., 2020·Frontiers in endocrinology·Free full text on PubMed Central
Polycystic ovary syndrome (PCOS) is a very common endocrine and metabolic disorder with the involvement of both genetic and environmental factors. Although much has been clarified on its pathogenesis, diagnosis, clinical manifestations, and therapy, there are still areas of uncertainty. To address fundamental concepts, novel aspects and hypotheses, and future perspectives, including the possible additional benefits of treatment with nutraceuticals, an expert consensus panel formed by endocrinologists and gynecologists was established. After an independent review of the literature, the panel convened electronically on February 3, 2020, and six resolutions were created, debated, and agreed upon discussion, and finally approved in their final form in a consensus livestream meeting held on April 15. The summary of the resolutions are: (1) PCOS is a well-established medical condition that negatively affects reproduction, general health, sexual health, and quality of life; (2) the symptoms and signs of PCOS appear early in life especially in female newborns from PCOS carriers; (3) women with PCOS have significantly increased risk of pregnancy-related complications including gestational diabetes mellitus; (4) a male PCOS equivalent exists, and it may impact on metabolic health and probably on reproduction; (5) the evidence supports that medical therapy for PCOS is effective, rational, and evidence-based; (6) the evidence supports a major research initiative to explore possible benefits of nutraceutical therapy for PCOS. The proposed resolutions may be regarded as points of agreement based on the current scientific evidence available.
Ferlin A et al., 2020·Journal of clinical medicine·Free full text on PubMed Central
About one-fifth of couples has fertility problems in Western countries. Male factors are present in about half of them, either alone or in combination with female causes. Therefore, both partners should be evaluated simultaneously. The fertility status and/or specific conditions of each partner influence the clinical and treatment approach. This article summarizes in a practical way when, how, and why the male partner of an infertile couple should be investigated. The available evidence and international guidelines were used, interpreting, discussing, and expanding them from personal decades-long experience in this field. The aim is to delineate the most appropriate clinical approach for the male partner of infertile couples, considering traditional and emerging technologies and laboratory analyses in the context of their clinical significance. Components of the initial evaluation in men without known risk factors for infertility should include at minimum medical history, physical examination, and semen analysis. Semen microbiological examination, endocrine assessment, scrotal ultrasound, and transrectal ultrasound are suggested in most men and are mandatory when specific risk factors for male infertility are known to be present or when the initial screening demonstrated abnormalities. Full examination, including genetic tests, testicular histology, or additional tests on sperm, is clinically oriented and/or suggested after the results of initial investigations.
Ethics in Embryo Research Task Force et al., 2020·Fertility and sterility
Scientific research using human embryos advances human health and offspring well-being and provides vital insights into the mechanisms for reproduction and disease. Research involving human embryos is ethically acceptable if it is likely to provide significant new knowledge that may benefit human health, well-being of the offspring, or reproduction.
Costello MF et al., 2019·Aust N Z J Obstet Gynaecol
Polycystic ovary syndrome (PCOS) is complex with reproductive, metabolic and psychological features. Infertility is a prevalent presenting feature of PCOS with approximately 75% of these women suffering infertility due to anovulation, making PCOS by far the most common cause of anovulatory infertility. Previous guidelines either lacked rigorous evidence-based processes, did not engage consumer and international multidisciplinary perspectives, or were outdated. This review paper aims to provide a brief update on the best available and most current research evidence supporting the treatment of PCOS which informed the recommendations in the assessment and treatment of infertility section of the international evidence-based guideline on PCOS 2018. International evidence-based guideline development engaged professional societies and consumer organisations with multidisciplinary experts and women with PCOS directly involved at all stages. Lifestyle change alone is considered the first-line treatment for the management of infertile anovulatory PCOS women who are overweight or obese. Letrozole should now be considered first-line pharmacological treatment for ovulation induction to improve fertility outcomes. Clomiphene citrate alone and metformin alone could also be used as first-line pharmacological therapy, although both are less effective than letrozole and metformin is less effective than clomiphene citrate in obese women. Gonadotrophins or laparoscopic ovarian surgery are usually second-line ovulation induction therapies. In the absence of an absolute indication for in vitro fertilisation (IVF) / intracytoplasmic sperm injection, women with PCOS and anovulatory infertility could be offered IVF as third-line therapy where firstor second-line ovulation induction therapies have failed. This review provides the best available evidence informing recommendations (along with clinical expertise and consumer preference) which provide clinicians with clear advice on best practice for the management of infertile women with PCOS.
Tan J et al., 2019·Current opinion in obstetrics & gynecology
The purpose of this review is to summarize and highlight recent critical advances in the diagnosis, classification, and management of adenomyosis.
Recent studies have clarified the specific mechanism through which adenomyotic lesions invade the underlying myometrium by epithelial-mesenchymal transition. Correlation studies using diagnostic MRI also strongly support the hypothesis of a different pathogenesis between the inner and outer myometrium forms of adenomyosis. Given advances in diagnostic imaging, several international organizations have also highlighted the importance of classification systems for adenomyosis. Finally, selective progesterone receptor modulators and gonadotropin-releasing hormone antagonists have demonstrated significant promise for treating pelvic pain and bleeding associated with adenomyosis, whereas novel fertility-preserving surgical techniques have been introduced to excise diffuse adenomyotic pathology while maintaining adequate uterine integrity.
Recent attempts at a uniform and reproducible classification system likely represent the first step for the development of a staging system for adenomyosis that can be correlated with the severity of clinical symptoms and promote an individualized therapeutic approach. Simultaneously, further insights into the etiology and pathogenesis as outlined in this review may also help in the development of targeted medical therapies.
Until recently there has been little evidence available to validate any method by which to make an accurate diagnosis of an osteoporotic vertebral fractures (OVFs) from plain radiographs. In part this reflects a lack of a completely satisfactory "gold standard," but primarily it relates to the absence of well-designed prospective studies in this context. Historically, OVFs were recognized by evidence of macroscopic structural failure in vertebrae using the criteria applied elsewhere in the skeleton. This comprised altered alignment, fragmentation, cortical disruptions, and breaks, among other changes. However, these morphological criteria were replaced by vertebral morphometry, referring to the use of quantitative or quasi-quantitative measurement tools for fracture diagnosis. Vertebral morphometry emerged as an understanding of and treatment for osteoporosis evolved, mainly in response to the need for expeditious assessments of large numbers of spine images for epidemiological and pharmaceutical purposes. Although most of the descriptions of such morphometric tools have stressed that they were not to be applied to clinical diagnosis with respect to individual patients, this constraint has been widely disregarded. Here we review the major attempts to develop a diagnostic strategy for OVF and describe their characteristics in adults and children. Recent evidence suggests that morphometric (quantitative; ie, based on measurement of dimensions and shape description) criteria are inferior to morphologic (qualitative; ie, based on structural integrity) vertebral damage assessment in identifying people with low bone density and at an increased risk of future fracture. Thus there is now an evidentiary basis for suggesting that morphological assessment is the preferred strategy for use in diagnosing OVF from radiographs.
Svedman C et al., 2019·Current Treatment Options in Allergy·Free to read
Purpose of the review: Textile dermatitis can sometimes be difficult to diagnose due to the fact that it is difficult to clinically suspect, and when allergic, patch test correctly and advice the patient as to what garments to avoid. Recent findings: The textile fibres as such are rarely the causative agent. Allergic contact dermatitis due to textiles is primarily caused by substances that are used to give the material certain qualities or performances. The textile dye mix, now in the baseline series, has proven to be a useful tool in diagnosing allergic contact dermatitis but additional patch testing with own material is advocated. Future research will hopefully facilitate the diagnostic procedure. This review is a short update on textile dermatitis, both irritant and allergic, the present recommendations regarding patch testing when suspecting contact allergy and the advice to give to those allergic that will hopefully help the clinician in daily work.
Ethics Committee of the American Society for Reproductive Medicine, 2019·Fertility and sterility
This Ethics Committee report outlines the interests, obligations, and rights of all parties involved in gamete and embryo donation: both males and females who choose to provide gametes or embryos for use by others, recipients of donated gametes and embryos, individuals born as a result of gamete or embryo donation, and the programs that provide donated gametes and embryos to patients. This document replaces the document "Interests, obligations, and rights of the donor in gamete donation," last published in 2014.
Ethics Committee of the American Society for Reproductive Medicine, 2019·Fertility and sterility
The Ethics Committee recommends that in vitro fertilization (IVF) centers develop patient-centered policies regarding requests for futile treatment. In most cases, clear communication can avoid a direct conflict, but clinicians ethically may refuse to provide treatment believed to be futile or to carry a very poor prognosis. In certain instances, clinicians may provide limited treatment which they judge likely to be futile, but must be vigilant in their presentation of risks, benefits, and alternatives. This version replaces the previous published draft of this name (Fertil Steril 2012;98:e6-9).
Vannuccini S et al., 2019·F1000Research·Free full text on PubMed Central
Adenomyosis is a benign uterine disorder in which endometrial glands and stroma are pathologically demonstrated in the uterine myometrium and it is considered a specific entity in the PALM-COEIN FIGO (polyp; adenomyosis; leiomyoma; malignancy and hyperplasia; coagulopathy; ovulatory dysfunction; endometrial; iatrogenic; and not yet classified - International Federation of Gynecology and Obstetrics) classification of causes of abnormal uterine bleeding (AUB). Although it has always been considered the classic condition of multiparous women over 40 years old who have pain and heavy menstrual bleeding, diagnosed at hysterectomy, the epidemiological scenario has completely changed. Adenomyosis is increasingly identified in young women with pain, AUB, infertility, or no symptoms by using imaging techniques such as transvaginal ultrasound and magnetic resonance. However, there is no agreement on the definition and classification of adenomyotic lesions from both the histopathology and the imaging point of view, and the diagnosis remains difficult and unclear. A uniform and shared reporting system needs to be implemented in order to improve our understanding on imaging features, their relationship with pathogenic theories, and their importance in terms of clinical symptoms and response to treatment. In fact, adenomyosis pathogenesis remains elusive and not a single theory can explain all of the different phenotypes of the disease. Furthermore, adenomyosis often coexists with other gynecological conditions, such as endometriosis and uterine fibroids, increasing the heterogeneity of available data. Treatment requires a lifelong management plan as the disease has a negative impact on quality of life in terms of menstrual symptoms, fertility, and pregnancy outcome and has a high risk of miscarriage and obstetric complications.
Policy and Regulation · Access and Coverage Policy
Van Der Poel S et al., 2018·Fertility and Sterility
There are reports that define the significant unmet need for access to fertility care and infertility interventions for heterosexual couples - those who experience involuntary childlessness and who desire a biological child. This need for access to care rarely measures those couples in non-heterosexual relationships, single individuals or in key/neglected populations. This disparity in recognition of need, and resultant lack of access to care is glaring. Universal access and attainment of the highest standard of care requires the provision of high-quality information and services that fulfills, protects and respects all individuals. The objective of this study was to identify the key principles that support access to fertility care and infertility interventions, and to provide a human rights framework to guide processes during the development of draft recommendations to the World Health Organization (WHO) for clinical practice. To evaluate the public health and human rights and gender impact on infertility, a literature review and systematic analysis were conducted to look at the following questions. What are the existing policies, public health directives and research evidence gaps impacting gender and human rights in the context of involuntary childlessness and infertility; and, What human rights principles guide the development and implementation of fertility care and infertility related laws, policies and systems? A detailed search strategy in collaboration with the WHO-HQ librarian, introducing various combinations of a predetermined set of terms was undertaken to identify primary literature, systematic reviews and gray literature, including documentation regarding current status of human rights and gender equality within policy and practices. Using the search strategy defined, we were able to identify 488 articles and documents, of which 102 were found appropriate. They were then categorized using 9 principles previously identified by WHO and used to address the topic of contraception. From this process, we generated a list of 12 principles which will be presented that cover issues such as non-discrimination, non-stigmatization as well as informed-decision making and autonomy, sharing of benefits and ensuring provision of care that includes the recognition of the health and well-being of the parent or parents as well as the children born. During the systematic review of the published data and evidence for the development of draft clinical recommendations to be presented to and for the World Health Organization consideration, it was clear that a human rights framework was required. Our systematic review process used research and policy evidence to support the development of a framework of principles that can better ensure different human rights dimensions are clearly and systematically integrated into the provision of fertility care information and fertility interventions and services.
We read with interest the editorial by Cummings and Eastell,1 A History of Pivotal Advances in Clinical Research in Bone and Mineral Diseases, published in a recent issue of the JBMR. In discussing such advances, they include spinal morphometry, and specifically refer to and illustrate the Genant semiquantitative (GSQ) paradigm,2 although also referring to the algorithm-based qualitative (ABQ) method3 of vertebral evaluation in the diagnosis of osteoporotic vertebral fractures (OVFs). Although in its day the GSQ method was a credible attempt at structured reporting, recent data suggest that GSQ grade 1 lesions, the most common, relate less well to bone density and fracture risk than comparable fractures diagnosed using the ABQ tool.4-6 Although morphometric methods may serve for understanding the epidemiology of osteoporotic fractures in large populations, it is much less certain that the GSQ method provides a basis for the care of individual patients. In a multidisciplinary context such as is served by this Journal, the endorsement of the GSQ method by the authors, without qualification, may well prove misleading. It is potentially invalid at the bedside and this should have been made explicit. We have observed a reluctance to give the presence of one or more vertebral fractures the importance they should be accorded because of confusion and ambiguity in the descriptive criteria and terminology used (eg, “wedging,” “deformity”) to define them. Perhaps the lack of a clear understanding of what might or might not constitute an OVF contributes to this disarray among radiologists and clinicians alike, again as noted recently by Szulc.7 Most of the many authors describing or reviewing “systems of morphometry,”8-12 such as in the current ASBMR primer,10 have cautioned that they are only to be used for epidemiological purposes. Moreover, most such reviews caution that positive findings should ideally be re-assessed by an “expert.” The danger, recognized by such constraints, is that of false-positive diagnoses from the clinical use of morphometry. In our experience, it is all too common for the iconic diagram provided by Dr. Genant to serve as a guide for the clinical evaluation of spinal images when that was not its intent. In the relevant article, Genant and colleagues2 were at pains to emphasize the importance of recognizing end-plate damage as evidence of OVF, but it has proved deceptively simple for readers to see only the diagram which Cummings and Eastell1 reproduce without noting these constraints. Historically the GSQ method was proposed as an attempt at structured diagnosis in fracture evaluation when such a concept was uncommon. Nevertheless it needs to be seen in perspective and it may have now outlived its usefulness. A great amount of admirable effort has gone into a structured understanding and diagnosis of atypical femoral fractures by the ASBMR.13 Those are, however, very rare events. Perhaps it is time to develop a comparable understanding of the much more common problem of OVF diagnosis to an extent the evidence allows. A taxonomy of such lesions is overdue. At present there are large differences in reported OVF incidence and prevalence for any given population. That fact probably reflects, at least in part, the method of diagnosis used, as much as any real insights into disease. None.
Ethics Committee of the American Society for Reproductive Medicine, 2018·Fertility and sterility
Professionals who discover misconduct or other undisclosed information that would be material to the participation of another party (such as a donor, gestational carrier, intended parent, or lawyer) in an assisted reproductive technology arrangement should encourage disclosure to that party. In some instances, it is ethically permissible for the physician either to disclose material information to the affected party or to decline to provide care. In all cases involving the legal status or rights of the parties, referral to legal professionals is advised. This document replaces the document of the same name, last published in 2014 (Fertil Steril 2014;101:38-42).
Ethics Committee of the American Society for Reproductive Medicine, 2018·Fertility and sterility
This document discusses the ethical implications of informing offspring about their conception using gamete or embryo donation. It replaces the 2013 ASRM Ethics Committee document of the same name (Fertil Steril 2013;100:45-9).
Ethics Committee of the American Society for Reproductive Medicine, 2018·Fertility and sterility
Preimplantation genetic testing for monogenic diseases for adult-onset conditions is ethically permissible for a range of conditions including when the condition is serious and no safe, effective interventions are available. The Committee strongly recommends that a genetic counselor experienced with PGT-M counsel patients considering such procedures. This document replaces the document titled "Use of preimplantation genetic diagnosis for serious adult-onset conditions: a committee opinion," last published in Fertil Steril 2013;100;54-7.
Ethics Committee of the American Society for Reproductive Medicine, 2018·Fertility and sterility
Posthumous gamete (sperm or oocyte) retrieval or use for reproductive purposes is ethically justifiable if written documentation from the deceased authorizing the procedure is available. Retrieval of sperm or eggs does not commit a center to their later use for reproduction, but may be permissible under the circumstances outlined in this opinion. Embryo use is also justifiable with such documentation. In the absence of written documentation from the decedent, programs open to considering requests for posthumous use of embryos or gametes should only do so when such requests are initiated by the surviving spouse or partner. This document replaces the report of the same name, last published in 2012.
Ethics Committee of the American Society for Reproductive Medicine, 2018·Fertility and sterility
Clinicians should encourage disclosure between intimate partners but must maintain confidentiality in cases where there is no prospect of harm to the partner and/or offspring. In cases where one member of a couple refuses to disclose relevant health information to the other partner and there exists a risk of harm to the unaware partner and/or offspring, clinicians may refuse to offer care and should decline to treat if full informed consent is not possible due to lack of disclosure.
Ethics Committee of the American Society for Reproductive Medicine, 2018·Fertility and sterility
Intended parents engage with gestational carriers in an attempt to achieve their personal reproductive goals. All gestational carriers have a right to be fully informed of the risks as well as the contractual and legal aspects of the gestational-carrier process. Gestational carriers have autonomy in making their own decisions regarding medical care and should be free from undue influences by the stakeholders involved. They should have free access to and receive psychological evaluation and counseling before, during, and after participating. Gestational carriers require independent legal counsel regarding the execution of contracts. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;99:1838-1841).
What is the optimal endometrial preparation protocol for a frozen embryo transfer (FET)?Summary answer Although the optimal endometrial preparation protocol for FET needs further research and is yet to be determined, we propose a standardized timing strategy based on the current available evidence which could assist in the harmonization and comparability of clinic practice and future trials. Amid a continuous increase in the number of FET cycles, determining the optimal endometrial preparation protocol has become paramount to maximize ART success. In current daily practice, different FET preparation methods and timing strategies are used.Study design, size, duration This is a review of the current literature on FET preparation methods, with special attention to the timing of the embryo transfer.Participants/materials, setting, methods Literature on the topic was retrieved in PubMed and references from relevant articles were investigated until June 2017.Main results and the role of chance The number of high quality randomized controlled trials (RCTs) is scarce and, hence, the evidence for the best protocol for FET is poor. Future research should compare both the pregnancy and neonatal outcomes between HRT and true natural cycle (NC) FET. In terms of embryo transfer timing, we propose to start progesterone intake on the theoretical day of oocyte retrieval in HRT and to perform blastocyst transfer at hCG + 7 or LH + 6 in modified or true NC, respectively.Limitations reasons for caution As only a few high quality RCTs on the optimal preparation for FET are available in the existing literature, no definitive conclusion for benefit of one protocol over the other can be drawn so far.Wider implications of the findings Caution when using HRT for FET is warranted since the rate of early pregnancy loss is alarmingly high in some reports.Study funding/competing interest(s) S.M. is funded by the Research Fund of Flanders (FWO). H.T. and C.B. report grants from Merck, Goodlife, Besins and Abbott during the conduct of the study.Trial registration number Not applicable.
Ethics Committee of the American Society for Reproductive Medicine, 2017·Fertility and sterility
Fertility programs may withhold services from prospective patients on the basis of well-grounded reasons that those patients will be unable to provide minimally adequate or safe care for offspring. This document was reviewed and updated; this version replaces the previous version of this document, last published July 2013 (Fertil Steril 2013;100:50-53).
Ethics Committee of the American Society for Reproductive Medicine, 2017·Fertility and sterility
Patient requests for transfer of embryos with genetic anomalies linked to serious health-affecting disorders detected in preimplantation testing are rare but do exist. This Opinion sets out the possible rationales for a provider's decision to assist or decline to assist in such transfers. The Committee concludes in most clinical cases it is ethically permissible to assist or decline to assist in transferring such embryos. In circumstances in which a child is highly likely to be born with a life-threatening condition that causes severe and early debility with no possibility of reasonable function, provider transfer of such embryos is ethically problematic and highly discouraged.
Ethics Committee of the American Society for Reproductive Medicine, 2017·Fertility and sterility
The use of adult intrafamilial gamete donors and gestational surrogates is generally ethically acceptable when all participants are fully informed and counseled, but consanguineous arrangements or ones that simulate incestuous unions should be prohibited. Adult child-to-parent arrangements require caution in order to avoid coercion, and parent-to-adult child arrangements are acceptable in limited situations. Programs that choose to participate in intrafamilial arrangements should be prepared to spend additional time counseling participants and ensuring that they have made free, informed decisions. This document replaces the document of the same name, last published in 2012 (Fertil Steril 2012;98:797-803).
Polycystic ovary syndrome (PCOS) is a highly prevalent disorder effecting reproductive-aged women worldwide. This article addresses the evolution of the criteria used to diagnosis PCOS; reviews recent advances in the phenotypic approach, specifically in the context of the extended Rotterdam criteria; discusses limitations of the current criteria used to diagnosis, particularly when studying adolescents and women in the peri- and postmenopause; and describes significant strides made in understanding the epidemiology of PCOS. This review recognizes that although there is a high prevalence of PCOS, there is increased variability when using Rotterdam 2003 criteria, owing to limitations in population sampling and approaches used to define PCOS phenotypes. Last, we discuss the distribution of PCOS phenotypes, their morbidity, and the role that referral bias plays in the epidemiology of this syndrome.
Informed Consent · Patient Preferences and Priorities
One of the most challenging scenarios in obstetric care occurs when a pregnant patient refuses recommended medical treatment that aims to support her well-being, her fetus's well-being, or both. In such circumstances, the obstetrician-gynecologist's ethical obligation to safeguard the pregnant woman's autonomy may conflict with the ethical desire to optimize the health of the fetus. Forced compliance-the alternative to respecting a patient's refusal of treatment-raises profoundly important issues about patient rights, respect for autonomy, violations of bodily integrity, power differentials, and gender equality. The purpose of this document is to provide obstetrician-gynecologists with an ethical approach to addressing a pregnant woman's decision to refuse recommended medical treatment that recognizes the centrality of the pregnant woman's decisional authority and the interconnection between the pregnant woman and the fetus.
Ethics Committee of the American Society for Reproductive Medicine, 2016·Fertility and sterility
This document presents arguments that conclude that it is unethical to use somatic cell nuclear transfer (SCNT) for infertility treatment due to concerns about safety; the unknown impact of SCNT on children, families, and society; and the availability of other ethically acceptable means of assisted reproduction. This document replaces the ASRM Ethics Committee report titled, "Human somatic cell nuclear transfer and cloning," last published in Fertil Steril 2012;98:804-7.
Ethics Committee of the American Society for Reproductive Medicine, 2016·Fertility and sterility
Advanced reproductive age (ARA) is a risk factor for female infertility, pregnancy loss, fetal anomalies, stillbirth, and obstetric complications. Oocyte donation reverses the age-related decline in implantation and birth rates of women in their 40s and 50s and restores pregnancy potential beyond menopause. However, obstetrical complications in older patients remain high, particularly related to operative delivery and hypertensive and cardiovascular risks. Physicians should perform a thorough medical evaluation designed to assess the physical fitness of a patient for pregnancy before deciding to attempt transfer of embryos to any woman of advanced reproductive age (>45 years). Embryo transfer should be strongly discouraged or denied to women of ARA with underlying conditions that increase or exacerbate obstetrical risks. Because of concerns related to the high-risk nature of pregnancy, as well as longevity, treatment of women over the age of 55 should generally be discouraged. This statement replaces the earlier ASRM Ethics Committee document of the same name, last published in 2013 (Fertil Steril 2013;100:337-40).
Ethics Committee of the American Society for Reproductive Medicine, 2016·Fertility and sterility
Cross-border reproductive care (CBRC) is a growing worldwide phenomenon, raising questions about why assisted reproductive technology (ART) patients travel abroad, what harms and benefits may result, and what duties health-care providers may have in advising and treating patients who travel for reproductive services. Cross-border care offers benefits and poses harms to ART stakeholders, including patients, offspring, providers, gamete donors, gestational carriers, and local populations in destination countries. This document replaces the previous document of the same name, last published in 2013 (Fertil Steril 2013;100:645-50).
Ethics Committee of the American Society for Reproductive Medicine, 2016·Fertility and sterility
Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. This opinion of the ASRM Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient informed consent. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;100:334-6).
Ethics Committee of the American Society for Reproductive Medicine, 2016·Fertility and sterility
Financial compensation of women donating oocytes for infertility therapy or for research is justified on ethical grounds and should acknowledge the time, inconvenience, and discomfort associated with screening, ovarian stimulation, and oocyte retrieval, and not vary according to the planned use of the oocytes, the number or quality of oocytes retrieved, the number or outcome of prior donation cycles, or the donor's ethnic or other personal characteristics. This document replaces the document of the same name, last published in 2007 (Fertil Steril 2007;88:305-9).
Ethics Committee of the American Society for Reproductive Medicine, 2016·Fertility and sterility
Medical providers have an ethical duty to disclose clinically significant errors involving gametes and embryos as soon as they are discovered. Clinics also should have written policies in place for reducing and disclosing errors. This document was reviewed and affirmed in 2015 and replaces the earlier document of the same name (Fertil Steril 2011;96:1312-4).
Ethics Committee of the American Society for Reproductive Medicine, 2016·Fertility and sterility
Building families through the adoption of children has been supported by human society throughout history. The ethical appropriateness of patients donating embryos to other patients for family building, or for research, is well established and is affirmed by this Committee. The use of the term ''adoption'' for embryos is inaccurate and should be avoided. This document replaces the ASRM Ethics Committee statement by the same name, last published in 2013 (Fertil Steril 2013;99:1846-7).
Does the prewash total motile sperm count (TMSC) have a better predictive value for spontaneous ongoing pregnancy (SOP) than the World Health Organization (WHO) classification system? The prewash TMSC shows a better correlation with the spontaneous ongoing pregnancy rate (SOPR) than the WHO 2010 classification system. According to the WHO classification system, an abnormal semen analysis can be diagnosed as oligozoospermia, astenozoospermia, teratozoospermia or combinations of these and azoospermia. This classification is based on the fifth percentile cut-off values of a cohort of 1953 men with proven fertility. Although this classification suggests accuracy, the relevance for the prognosis of an infertile couple and the choice of treatment is questionable. The TMSC is obtained by multiplying the sample volume by the density and the percentage of A and B motility spermatozoa. STUDY DESIGN, SIZE, We analyzed data from a longitudinal cohort study among unselected infertile couples who were referred to three Dutch hospitals between January 2002 and December 2006. Of the total cohort of 2476 infertile couples, only the couples with either male infertility as a single diagnosis or unexplained infertility were included (n = 1177) with a follow-up period of 3 years. PARTICIPANTS/MATERIALS, SETTING, In all couples a semen analysis was performed. Based on the best semen analysis if more tests were performed, couples were grouped according to the WHO classification system and the TMSC range, as described in the Dutch national guidelines for male infertility. The primary outcome measure was the SOPR, which occurred before, during or after treatments, including expectant management, intrauterine insemination, in vitro fertilization or intracytoplasmic sperm injection. After adjustment for the confounding factors (female and male age, duration and type of infertility and result of the postcoital test) the odd ratios (ORs) for risk of SOP for each WHO and TMSC group were calculated. The couples with unexplained infertility were used as reference. MAIN A total of 514 couples did and 663 couples did not achieve a SOP. All WHO groups have a lower SOPR compared with the unexplained group (ORs varying from 0.136 to 0.397). Comparing the couples within the abnormal WHO groups, there are no significant differences in SOPR, except when oligoasthenoteratozoospermia is compared with asthenozoospermia [OR 0.501 (95% CI 0.311-0.809)] and teratozoospermia [OR 0.499 (95% CI: 0.252-0.988)], and oligoasthenozoospermia is compared with asthenozoospermia [OR 0.572 (95% CI: 0.373-0.877)]. All TMSC groups have a significantly lower SOPR compared with the unexplained group (ORs varying from 0.171 to 0.461). Couples with a TMSC of <1 × 10(6) and 1-5 × 10(6) have significantly lower SOPR compared with couples with a TMSC of 5-10 × 10(6) [respectively, OR 0.371 (95% CI: 0.215-0.64) and OR 0.505 (95% CI: 0.307-0.832)]. LIMITATIONS, To include all SOPs during the follow-up period of 3 years, couples were not censured at the start of treatment. Roughly, three prognostic groups can be discerned: couples with a TMSC <5, couples with a TMSC between 5 and 20 and couples with a TMSC of more than 20 × 10(6) spermatozoa. We suggest using TMSC as the method of choice to express severity of male infertility. None.
Nowosielski K et al., 2015·International Journal of Gynecology & Clinical Practices·Free to read
The presences of sexual dysfunctions in women were not a subject of scientific debate until the 21st century. At the beginning of the new millennium interdisciplinary groups of scientists agreed that female sexuality and sexual dysfunctions have to be taken seriously and analyzed independently of male sexuality. Finally, Rosemary Basson's description of the cyclic model of sexual response resulted in abandon of the linear model, which was characteristic for male sexual response, and creating circular models of female sexual response. The researchers are still studying the nature of sexual pain in women. The aim of this article is to interest physicians, especially gynaecologists, in aetiology and treatment options for chronic pelvic pain syndrome (CPPS). The causes of CPPS may lie in sexual disorders which were until recently classified by the American Psychiatric Association in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) as dyspareunia and vaginismus and changed in DSM-5 to Genito-Pelvic Pain/Penetration Disorder (GPPD). The DSM-5 classification emphasizes treatment focusing on elimination fear and anxiety more than on relaxation of vaginal muscles. Therapeutic experience confirms that such an approach is well-grounded; a therapy focusing on non-organic factors gives excellent and promising results. If we point to the necessity of introducing changes in the approach to treatment of GPPD, then we also have to allow for the role of fear and anxiety in the aetiology of these disorders. The Fear-Avoidance Model - FAM – presented in this article gives a scientific bases for psychological treatment of CPPS.
Fertility and Outcomes · Conception After Excision
Fadhlaoui A et al., 2015·Front Surg·Free full text on PubMed Central
Endometriosis is defined as the presence of endometrial-like tissue (glands or stroma) outside the uterus, which induces a chronic inflammatory reaction. Although endometriosis impairs fertility, it does not usually completely prevent conception. The question of evidence based-medicine guidelines in endometriosis-associated infertility is weak in many situations. Therefore, we will highlight in this issue where the challenges are.
Measurement and Statistics · Instrument Development and Validation
Becker CM et al., 2014·Fertil Steril·Free full text on PubMed Central
To standardize the recording of surgical phenotypic information on endometriosis and related sample collections obtained at laparoscopy, allowing large-scale collaborative research into the condition.
An international collaboration involving 34 clinical/academic centers and three industry collaborators from 16 countries.
Two workshops were conducted in 2013, bringing together 54 clinical, academic, and industry leaders in endometriosis research and management worldwide. PATIENT(S): None. INTERVENTION(S): A postsurgical scoring sheet containing general and gynecological patient and procedural information, extent of disease, the location and type of endometriotic lesion, and any other findings was developed during several rounds of review. Comments and any systematic surgical data collection tools used in the reviewers' centers were incorporated. MAIN OUTCOME MEASURE(S): The development of a standard recommended (SSF) and minimum required (MSF) form to collect data on the surgical phenotype of endometriosis. RESULT(S): SSF and MSF include detailed descriptions of lesions, modes of procedures and sample collection, comorbidities, and potential residual disease at the end of surgery, along with previously published instruments such as the revised American Society for Reproductive Medicine and Endometriosis Fertility Index classification tools for comparison and validation. CONCLUSION(S): This is the first multicenter, international collaboration between academic centers and industry addressing standardization of phenotypic data collection for a specific disease. The Endometriosis Phenome and Biobanking Harmonisation Project SSF and MSF are essential tools to increase our understanding of the pathogenesis of endometriosis by allowing large-scale collaborative research into the condition.
Measurement and Statistics · Research Tooling and Reproducibility
To determine the variability in the recognition of normal sperm and various sperm defects using the strict criteria recommended by the World Health Organization (5th edition, 2010). Sperm morphologic assessment by three experienced evaluators. Image processing laboratory and reproduction research institute. PATIENT(S): Semen donors from a sperm bank. INTERVENTION(S): The morphology of 5,296 sperm was evaluated using statistical analyses of variability. MAIN OUTCOME MEASURE(S): The proportion and coefficients of variation (CVs) of normal sperm, defects of specific parts, and the categories of defects were measured. The degree of agreement between any two of the three evaluators was calculated. The multiple anomalies index, teratozoospermia index, sperm deformity index, and the CVs were also measured. RESULT(S): The CVs of normal sperm, multiple anomalies index, teratozoospermia index, and sperm deformity index were 4.80%, 4.14%, 5.75%, and 6.81%, respectively. A broader range (4.80%-132.97%) of CVs was observed for the recognition of various defects. The coefficients of the degree of agreement concerning specific morphologic parts of sperm varied (0.387-0.607), with lower relative values for the head and mid-piece than for the tail and cytoplasm. CONCLUSION(S): The sperm head is more difficult to evaluate than the other parts using the criteria recommended by the World Health Organization in 2010. The degree of agreement concerning specific parts and various defects varied in broad ranges. A stricter definition for each defect is needed.
Prescribing Safety · Medication Safety in Pregnancy
Kimber-Trojnar Ż et al., 2014·Current pharmaceutical biotechnology
The clinical recognition and adequate treatment of women with hyperglycemia during pregnancy is significant in order to reduce neonatal complications correlated with gestational diabetes mellitus (GDM). The traditional management of pregnant patients with GDM in whom diet restriction is not sufficient enough involves subcutaneous insulin administration. However, insulin therapy has several disadvantages. It is therefore highly desirable to find an effective alternative to insulin. Glyburide (also known as glibenclamide) is currently classified as Category C by the U.S. Food and Drug Administration (FDA) for use in pregnancy. Despite the fact that the FDA does not approve glyburide for the treatment of GDM, the American College of Obstetricians and Gynecologists (ACOG) recommended in 2013 that: "when pharmacologic treatment of GDM is indicated, insulin and oral medications are equivalent in efficacy, and either can be an appropriate first-line therapy". These conflicting standpoints result from published contradictory data concerning the risks and benefits of the use of glyburide for the treatment of women with GDM. In this focused review we first present the current state of knowledge about the pharmacokinetics and pharmacodynamics of glyburide, including aspects of the transplacental transport and placental metabolism of the drug, and then we comment on several clinical studies describing the use of glyburide for the treatment of women with GDM. Since the contradictory data primarily concern the transfer of glyburide across the placenta, further rigorous scientific researches focusing on this issue are required in order to develop evidence-based recommendations for the use of glyburide for the treatment of women with GDM.
Measurement and Statistics · Research Tooling and Reproducibility
Schliep KC et al., 2012·Obstet Gynecol·Free full text on PubMed Central
To estimate the interrater and intrarater reliability of endometriosis diagnosis and severity of disease among gynecologic surgeons viewing operative digital images. The study population comprised a random sample (n=148 [36%]) of women who participated in the Endometriosis: Natural History, Diagnosis and Outcomes study. Four academic expert and four local, specialized expert surgeons reviewed the images, diagnosed the presence or absence of endometriosis for each woman, and rated severity using the revised American Society for Reproductive Medicine (ASRM) criteria. Interrater-level and intrarater-level agreement were calculated for both endometriosis diagnosis and staging. The interrater reliability for endometriosis diagnosis among the eight surgeons was substantial: Fleiss κ=0.69 (95% confidence interval [CI] 0.64-0.74). Surgeons agreed on revised ASRM endometriosis staging criteria after experienced assessment in a majority of cases (mean 61%, range 52-75%) with moderate interrater reliability: Fleiss κ=0.44 (95% CI 0.41-0.47). The intrarater reliability for experienced assessment compared with computer-assisted revised ASRM staging was almost perfect (mean weighted κ=0.95, range 0.89-0.99). Substantial reliability was found for revised ASRM endometriosis diagnosis, whereas moderate reliability was observed for staging. Almost perfect reliability was observed for surgeons' rating of disease severity compared with computerized-assisted, checklist-based staging. Findings suggest that reliability in endometriosis diagnosis is not greatly altered by location or composition of surgeons, supporting the conduct of multisite studies or compilation of endometriosis data across clinical centers. Although surgeons appear to be skilled at assessing endometriosis stage intuitively, how staging of disease burden correlates with clinical outcomes remains to be developed.
Leslie WD et al., 2011·Osteoporos Int·Free full text on PubMed Central
A procedure for creating a simplified version of fracture risk assessment tool (FRAX®) is described. Calibration, fracture prediction, and concordance were compared with the full FRAX tool using two large, complementary Canadian datasets.
The Canadian Association of Radiologists and Osteoporosis Canada (CAROC) system for fracture risk assessment is based upon sex, age, bone mineral density (BMD), prior fragility fracture, and glucocorticoid use. CAROC does not require computer or web access, and categorizes 10-year major osteoporotic fracture risk as low (<10%), moderate (10-20%), or high (>20%). Basal CAROC fracture risk tables (by age, sex, and femoral neck BMD) were constructed from Canadian FRAX probabilities for major osteoporotic fractures (adjusted for prevalent clinical risk factors). We assessed categorization and fracture prediction with the updated CAROC system in the CaMos and Manitoba BMD cohorts. The new CAROC system demonstrated high concordance with the Canadian FRAX tool for risk category in both the CaMos and Manitoba cohorts (89% and 88%). Ten-year fracture outcomes in CaMos and Manitoba BMD cohorts showed good discrimination and calibration for both CAROC (6.1-6.5% in low-risk, 13.5-14.6% in moderate-risk, and 22.3-29.1% in high-risk individuals) and FRAX (6.1-6.6% in low-risk, 14.4-16.1% in moderate-risk, and 23.4-31.0% in high-risk individuals). Reclassification from the CAROC risk category to a different risk category under FRAX occurred in <5% for low-risk, 20-24% for moderate-risk, and 27-30% for high-risk individuals. Reclassified individuals had 10-year fracture outcomes that were still within or close to the original nominal-risk range.. The new CAROC system is well calibrated to the Canadian population and shows a high degree of concordance with the Canadian FRAX tool. The CAROC system provides s a simple alternative when it is not feasible to use the full Canadian FRAX tool.
Measurement and Statistics · Instrument Development and Validation
To develop a clinical tool that predicts pregnancy rates (PRs) in patients with surgically documented endometriosis who attempt non-IVF conception.
Prospective data collection on 579 patients and comprehensive statistical analysis to derive a new staging system--the endometriosis fertility index (EFI)--from data rather than a priori assumptions, followed by testing the EFI prospectively on 222 additional patients for correlation of predicted and actual outcomes.
Private reproductive endocrinology practice.
PATIENT(S): A total of 801 consecutively diagnosed and treated infertile patients with endometriosis.
INTERVENTION(S): Surgical diagnosis and treatment followed by non-IVF fertility management.
MAIN OUTCOME MEASURE(S): The EFI and life table PRs.
RESULT(S): A statistically significant variable used to create the EFI was the least function score (i.e., the sum of those scores determined intraoperatively after surgical intervention that describe the function of the tube, fimbria, and ovary on both sides). Sensitivity analysis showed that the EFI varies little, even with variation in the assignment of functional scores, and predicted PRs.
CONCLUSION(S): The EFI is a simple, robust, and validated clinical tool that predicts PRs after endometriosis surgical staging. Its use provides reassurance to those patients with good prognoses and avoids wasted time and treatment for those with poor prognoses.
The Congregation of the Doctrine of the Faith’s Dignitas personae doesnotofferadefinitiverejectionofthepracticeofhumanembryoadoptionas intrinsicallyevil,butneitherdoesitsimplyleavethematteran“openquestion.” The document does indeed oppose the practice, but its reasons for doing so are notclearlystatedandseemtobeintensionwithitsownaffirmationsofthe personal dignity of embryos and the goodness of adoption. The Congregation’s opposition is therefore best read as a prudential judgment that embryo adoption cannotbejustifiedinthepresentcircumstancesduetothepotentialforscandal and the cooperation with the fertility industry which it involves. National Catholic Bioethics Quarterly 10.2(Summer2010):307–328.
The impact of clinical risk factor-based absolute risk methods on the prevalence of high risk for osteoporotic fracture is unknown. We applied absolute risk methods to 6646 subjects and found that the prevalence of elderly women deemed to be at high risk increased substantially, whereas the overall prevalence was highly dependent on the threshold used to designate high risk.
Many groups have advocated using absolute risk methods that incorporate clinical risk factors to target patients for osteoporosis therapy. We examined how the application of such absolute risk classification systems influences the prevalence of those considered to be at high risk for osteoporotic fracture and compared these systems to one based solely on BMD. Using 6646 subjects from the Canadian Multicentre Osteoporosis Study (CaMos), a prospective, randomly selected, population-based cohort, we assessed three different systems for determining prevalence of high risk for osteoporotic fracture: a BMD-based system; a simplified risk factor system incorporating age, sex, BMD, and two clinical risk factors; and a comprehensive system, incorporating age, sex, BMD, and seven clinical risk factors. The 10-year absolute risks of incident fragility fracture were compared across systems using three different high-risk thresholds. The prevalence of a T score < or = -2.5 was 18.8% (95% CI: 17.7-19.9%) in women and 3.9% (95% CI: 3.0-4.7%) in men. Using a 15% 10-year risk of fracture threshold, the prevalence of women at high risk increased to 46.9% (95% CI: 45.4-48.4) and 42.5% (95% CI: 41.1-43.9) when the comprehensive and simplified risk factor classification systems were used, respectively. Using a 25% 10-year absolute risk threshold, the prevalence of high risk was similar to that of the BMD-based system, whereas the 20% threshold gave intermediate rates. All thresholds analyzed resulted in an increased prevalence of older women at high risk for fracture, whereas only the 15% 10-year risk of fracture threshold resulted in an increase in the prevalence of men at high risk. The application of risk factor-based systems results in an increased prevalence of older women at high risk. The prevalence of individuals at high risk may increase with changes to the methods used to determine those who are eligible for therapy. These data have important implications for the pattern of care and costs of treating osteoporotic fractures.
Since the 1990 National Institutes of Health-sponsored conference on polycystic ovary syndrome (PCOS), it has become appreciated that the syndrome encompasses a broader spectrum of signs and symptoms of ovarian dysfunction than those defined by the original diagnostic criteria. The 2003 Rotterdam consensus workshop concluded that PCOS is a syndrome of ovarian dysfunction along with the cardinal features hyperandrogenism and polycystic ovary (PCO) morphology. PCOS remains a syndrome, and as such no single diagnostic criterion (such as hyperandrogenism or PCO) is sufficient for clinical diagnosis. Its clinical manifestations may include menstrual irregularities, signs of androgen excess, and obesity. Insulin resistance and elevated serum LH levels are also common features in PCOS. PCOS is associated with an increased risk of type 2 diabetes and cardiovascular events.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Clinical and instructional decision trees guide practitioners through the interpretation of chart findings and the selection of appropriate responses — ranging from continued observation to medical referral — based on pattern recognition and established CrMS criteria. Systematic decision-making protocols reduce practitioner variability, support evidence-based care, and define the threshold at which observed abnormalities warrant further NaProTECHNOLOGY medical evaluation.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
A quantitative taxonomy for classifying the cervical mucus cycle is established, using standardized descriptors for mucus type, quantity, consistency, and Peak Day timing to produce objectively comparable cycle profiles across patients and study populations. This classification system is indispensable to NaProTECHNOLOGY research and clinical correlation, as it enables the linkage of specific mucus pattern anomalies to underlying endocrine pathology.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Serial transvaginal ultrasound monitoring of follicular dynamics -- growth, rupture, corpus luteum formation, and free fluid -- forms the basis of a systematic classification of human ovulation disorders, including anovulation, luteinized unruptured follicle (LUF), follicular arrest, premature luteinization, and PCOS-type patterns. Anchoring sonographic findings to the CrMS Peak day allows precise correlation between ultrasound events and cervical mucus biomarkers, creating a reproducible diagnostic taxonomy that drives targeted medical and surgical treatment within the NaProTECHNOLOGY framework.
Fertility and Outcomes · Conception After Excision
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Endometriosis impairs fertility through direct mechanical distortion of pelvic anatomy, peritoneal inflammatory mediators, and hormonal micro-environment alterations that reduce implantation potential, making thorough surgical excision critical to restoring fertility rather than bypassing it. The PEARS classification system, used in NaProTECHNOLOGY surgical practice, enables standardized documentation of endometriotic disease extent and correlates operative findings with postoperative reproductive outcomes.
Identification of women with low bone mineral density (BMD) is an important strategy in reducing the incidence of osteoporotic fractures. However, screening all women is not recommended. To assess the diagnostic properties of 4 decision rules--Simple Calculated Osteoporosis Risk Estimation (SCORE), Osteoporosis Risk Assessment Instrument (ORAI), Age, Body Size, No Estrogen (ABONE), and body weight less than 70 kg (weight criterion)--for selecting women for dual-energy x-ray absorptiometry (DXA) testing and to compare results with recommendations made in the National Osteoporosis Foundation (NOF) practice guidelines. DESIGN AND Analysis of data from the Canadian Multicentre Osteoporosis Study, a population-based community sample, collected from 9 study centers across Canada between February 1996 and September 1997. Postmenopausal women aged 45 years or older (N = 2365) without bone disease who had DXA data for the femoral neck, data to apply selection criteria, and who were not currently taking estrogens or who had been taking hormone replacement therapy for 5 or more years. Sensitivity, specificity, and area under the receiver operating characteristic (AUROC) curve of each of the 4 decision rules and the NOF guidelines for identifying women with a BMD T score of less than -1.0 SD, less than -2.0 SD, and no more than -2.5 SD at the femoral neck, and percentages of women recommended for testing, stratified by BMD level and age. The percent of women with a BMD T score less than -1, less than -2, and no more than -2.5 were 68.3%, 25.4%, and 10.0%, respectively. The AUROC curves were greatest using SCORE and ORAI. The sensitivity for identifying women with a BMD T score of less than -2.0 was 93.7% (95% confidence interval [CI], 91.8%-95.6%) using the NOF guidelines and was 97.5% (95% CI, 96.3%-98.8%), 94.2% (95% CI, 92.3%-96.1%), 79.1% (95% CI, 75.9%-82.3%), and 79.6% (95% CI, 76.4%-82.8%), respectively, using the SCORE, ORAI, ABONE, and weight criterion. However, the NOF guidelines also resulted in 74.4% (95% CI, 71.3%-77.6%) of women with a normal BMD (T score of -1.0 or higher) being tested compared with 69.2% (95% CI, 65.9%-72.5%), 56.3% (95% CI, 52.7%-59.8%), 35.8% (95% CI, 32.4%-39.2%), and 38.1% (95% CI, 34.6%-41.6%), respectively, using the 4 decision rules. Assessments suggest that ABONE and weight criterion are not useful case-finding approaches. The SCORE and ORAI decision rules are better than the NOF guidelines at targeting BMD testing in high-risk patients. The acceptability of these rules in clinical practice merits further investigation given their potential effect on the use of densitometry services.
There is considerable evidence that the childbearing years represent a time when women are highly vulnerable to developing mood disorders. Prospective, cross-sectional, and retrospective studies have demonstrated that more than 10% of new adult mothers will experience a major depressive episode during the first postpartum year. Changes in the health care delivery system will result in increased pressure on the obstetrician/gynecologist to identify and treat women with postpartum-onset depression. Despite shortcomings in the available literature, prospective studies have identified risk factors for developing postpartum depression. Furthermore, the clear overlap between the normal sequelae of childbirth and the symptoms of major depression, including alterations in sleep, energy, libido, appetite, and body weight, underscores the need to develop guidelines for early identification. We furnish a brief overview of postpartum mood disorders with a primary focus on the antenatal and postnatal risk factors for developing postpartum depression. Based on the extent literature and our clinical experience, a set of recommendations for early identification and treatment is provided.
In a 3-year prospective study of 643 consecutive laparoscopies for infertility, pelvic pain, or infertility and pain, the pelvic area, the depth of infiltration, and the volume of endometriotic lesions were evaluated. The incidence, area, and volume of subtle lesions decreased with age, whereas for typical lesions these parameters and the depth of infiltration increased with age. Deeply infiltrating endometriosis was strongly associated with pelvic pain, women with pain having larger and deeper lesions. Because deep endometriosis has little emphasis in the revised American Fertility Society classification and after analyzing the diagnoses made in each class, considerations for a simplifying revision with inclusion of deep lesions are suggested. In conclusion, suggestive evidence is presented to support the concept that endometriosis is a progressive disorder, and it is demonstrated that deep endometriosis is strongly associated with pelvic pain.
Functional psychosis in the puerperal period is a dramatic phenomenon that presents a unique set of diagnostic and therapeutic challenges. Despite its omission from modern classificatory systems such as DSM-III and DSM-III-R, the concept of puerperal psychosis continues to receive support from clinicians on the basis of the apparently distinctive clinical picture that characterizes psychoses occurring at this time. The range of possible nosological models is considered in light of relevant studies of puerperal illness, and the evidence for and against each model is presented. The question of the prognosis of puerperal psychosis is reviewed and guidelines for its estimation in the individual case proposed. The heuristic importance of puerperal psychosis in terms of basic research and preventive psychiatry is also stressed.
Fertility and Outcomes · Conception After Excision
A homogeneous group of 214 infertile women with endometriosis treated at the Johns Hopkins Hospital from 1960 to 1979 received conservative surgery as the sole therapeutic modality. Among this group, 115 patients (54%) conceived following surgery; of these conceptions, 109 resulted in a living child. Among 49 patients with secondary infertility, the spontaneous abortion rate was reduced from 49% to 20% after conservative surgery (P less than or equal to 0.01). Three contemporary classification systems were utilized to categorize patients according to the sites and amount of endometriosis at the time of conservative surgery. Those systems suggested by Buttram (Fertil Steril 30:240, 1978) and by Kistner and coauthors (Fertil Steril 28:108, 1977) revealed differences among fecundability rates among the different categories (P less than or equal to 0.01); however, the system suggested by The American Fertility Society (AFS) (Fertil Steril 32:633, 1979) revealed significant differences only if categories were combined (mild plus moderate versus severe plus extensive, P less than or equal to 0.05). Nevertheless, the AFS system revealed that pregnancy success was significantly reduced if an ovarian endometrioma was greater than 3 cm or had ruptured (P less than or equal to 0.01).
Lack of standardization in analytic methods for assigning infertility data is attributed to inadequate classification of fertility problems, and a lack of consistent methodology in evaluating outcome of infertility therapy. A classification scheme ideally should consider types of fertility problems as well as clinical assessment of its severity. Until an adequate classification system is developed, researchers are encouraged to describe fully the nature of infertility problem examined, and present results for homogenous groups of patients. The life-table method of analysis is a useful technique for assessing infertility statistics. The starting point of this method should depend on the group examined and may be either the date of 1st visit to the clinic or the date that therapy is instituted. Approximate date of conception should be the endpoint. A mathematical model of infertility predicated on the assumption that there is a constant monthly probability of conception of fecundability can be used to derive equations with potential for clinical application.
A discussion of infertility would be incomplete without a comment on the changing concepts of the definition. For statistical purposes it may be necessary to retain the criterion of a three year barren marriage. However, for the most satisfactory therapeutic results it appears that investigations for infertility must be instituted before these three, possibly most valuable, years have been wasted. The validity of shortening the period is substantiated by work of Diddle1 and Guttmacher,2 who independently obtained a figure of six months as the average time for a normal couple to achieve pregnancy. Relative infertility may be considered to exist any time after a six month interval. As late marriages and prolonged use of contraceptives are an integral part of our present society (especially in the private practice group) the foregoing fact is extremely important. Patients who marry after the age of 28 are contending, after a three