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Well-designed and -conducted clinical trials are needed to further advance the field for reproductive medicine. However, current reporting of outcomes of trials is ambiguous and disparate. In this review it is offered that the preferred outcome for clinical trials in reproductive medicine should be live birth. Multiple births should be listed, and it should be specified whether this is multiple births per couple or multiple births per conception. The unit of measure should be women (or couples) and not cycles. The duration of exposure should also be clearly identified (i.e., treatment was one cycle, a prespecified number of cycles, or a period of time). Pregnancy loss should be specified, and the denominator should be those who conceived. Although live birth is the primary outcome, complications should be defined and reported, including multiple births and other objective markers, such as preterm delivery, small-for-gestational age, or stillbirth. [Copyright &y& Elsevier]

A biomarker can be used for early diagnosis of a disease, identification of individuals for disease prevention, as a potential drug target, or as a potential marker for a drug response. A biomarker may also limit the use of drug (and therefore costs) to the population of patients for which the drug will be safe and efficacious. A biomarker in reproduction could be used to improve assessment of exposure, identify subgroups susceptible to treatment, predict outcome, and/or differentiate subgroups with potentially different etiologies of disease. Despite many potential uses there is low participation in reproductive biology to develop molecular biomarkers, which may be directly related to the low number of new molecular entities entering clinical trials. As the number of candidate markers in reproductive medicine is increasing, it is important to understand the pathway of development from discovery to clinical utility and recognize that the vast majority of potential markers will not be clinically useful, owing to a variety of pitfalls. Extensive testing, validation, and modification needs to be performed before a biomarker is demonstrated to have clinical utility. New opportunities and partnerships exist and should hasten the development of biomarkers in reproduction. As more biomarkers are moved into practice, a better-educated biomarker consumer will enhance the possibility that biomarker(s) will realize their great potential. [ABSTRACT FROM AUTHOR]

The National Institute of Child Health and Human Development has conducted a series of vision workshops to set an ambitious but tenable broad agenda, transcending traditional organizational and disciplinary boundaries. This presentation sets forth a vision regarding how the aspects of a woman’s reproductive lifespan are interrelated, likely starting from childhood all the way to the later reproductive years. As a woman propagates, this circular interaction is then transmitted to the next generation. We need an understanding of the clinical processes, the time course, the natural history, and disruptors of these processes. With that understanding, we can then bring tools to bear to assess these issues, whether these tools are epidemiology, demography, social science, molecular biology, proteomics, genomics, or epigenomics. Our future research agenda should investigate how reproduction affects health and how health affects reproduction. [ABSTRACT FROM AUTHOR]

Reports on a study to examine the association between infant exposure to soy-based formula and health in young adulthood, with an emphasis on reproductive health. Context; Objective; Design, setting, and participants; Main outcome measures; Results; Conclusions.

The majority of perinatal morbidity after in vitro fertilization (IVF) is due to multiple pregnancy; however, even singleton infants are at an increased risk for adverse outcomes. We have summarized data that evaluates adverse outcomes in IVF infants and recent attempts to delineate the underlying causes of this risk. We submit that practitioners of reproductive medicine should remain at the forefront of this investigation. [Copyright &y& Elsevier]

The science of contraceptive medicine and reproductive medicine are similar. At present contraceptive medicine has moved beyond understanding the mechanism of action of steroid hormones with the introduction of many safe and effective methods. Long-acting reversible contraceptives are increasing in acceptance and providing very high efficacy. The science has pivoted toward optimization of family planning in selected high-risk populations, such as those with a high-risk of thrombosis, as well as addressing the challenge of obesity. The pipeline for male and female related methods will continue to advance the science and public health impact. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine. In this series in Fertility and Sterility, several aspects of RCTs are discussed, with contributions on multicenter RCTs, different international settings, and integrity of RCTs. The present contribution deals with methodologic issues. We discuss different types of RCTs based on null hypothesis (superiority vs. noninferiority vs. equivalence) as well as frequentist versus Bayesian interpretation. We also discuss the use of RCTs in the era of personalized medicine and RCTs to address diagnostic and prognostic questions. Finally, we address the use of big data compared with the use of RCTs. [ABSTRACT FROM AUTHOR]

The use of estrogens and progestins in reproductive medicine is widespread and has spanned decades. Often the effect is therapeutic, but sometimes its use has unintended consequences. In this Views and Reviews, old and new indications for the use of ovarian sex steroids are examined with attention to updating knowledge, breaking bad habits, and providing evidence for use (or nonuse). [ABSTRACT FROM AUTHOR]

The trend toward a decline in the percentage of women with infertility in the United States appears real. While the factors associated with this trend are likely many, complex, and interrelated, we cannot overlook the positive impact of those individuals who practice in the field of reproductive medicine. [Copyright &y& Elsevier]

To date, recurrent implantation failure (RIF) has no clear definition and no clearly identified impaired function. Hence, the term RIF is currently used somewhat haphazardly, on the basis of clinicians' judgment. International experts in reproductive medicine met on July 1, 2022, in Lugano, Switzerland, to review the different facets of RIF and define the diagnosis and its appropriate management. A systematic review without meta-analysis of studies published in English from January 2015 to May 2022. Data indicated that RIF has been largely overevaluated, overdiagnosed, and overtreated without sufficient critical assessment of its true nature. Our analyses show that true RIF is extremely uncommon—occurring in <5% of couples with infertility—and that reassurance and continued conventional therapies are warranted in most cases of assisted reproductive technology (ART) failure. Although the true biologic determinants of RIF may exist in a small subset of people with infertility, they elude the currently available tools for assessment. Without identification of the true underlying etiology(ies), it is reasonable not to assign this diagnosis to a patient until she has failed at least 3 euploid blastocyst transfers (or the equivalent number of unscreened embryo transfers, adjusted to the patient's age and corresponding euploidy rate). In addition, other factors should be ruled out that may contribute to her reduced odds of sustained implantation. In such cases, implantation failure should not be the only issue considered in case of ART failure because this may result from multiple other factors that are not necessarily repetitive or persistent. In reality, RIF impacting the probability of further ART success is a very rare occurrence. True RIF is extremely uncommon, occurring in <5% of couples with infertility. Reassurance and continued conventional therapies are warranted in most cases. It would seem reasonable not to assign this diagnosis to a patient until she has failed at least 3 euploid embryo transfers (or the equivalent number of unscreened embryos, adjusted to her age). Given the number of internationally recognized experts in the field present at the Lugano meeting 2022, our publication constitutes a consensus statement. [ABSTRACT FROM AUTHOR]

Objective: To determine if Chlamydia trachomatis (C. trachomatis) seropositivity, as detected by the C. trachomatis elementary body (EB)-based enzyme-linked immunosorbent assay [EB ELISA] predicts pregnancy and pregnancy outcome among infertile women with documented tubal patency.Design: Cohort study.Setting: Outpatient clinics.Patient(s): In all, 1,250 infertile women with documented tubal patency enrolled in 1 of 2 randomized controlled trials: Pregnancy in Polycystic Ovary Syndrome II; and the Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation.Intervention(s): Sera were analyzed for anti-C. trachomatis immunoglobulin G (IgG)1 and IgG3 antibodies, using a research C. trachomatis EB ELISA. The optical density (OD)405 readings of ≥ 0.35 and ≥ 0.1 were considered positive for IgG1 and IgG3, respectively.Main Outcome Measure(s): Primary outcomes included pregnancy, live birth, and ectopic pregnancy. Log-linear regression was used to determine the relative risk after adjusting for age, race, treatment medication, smoking status, and current alcohol use.Result(s): A total of 243 (19%) women were seropositive for anti-C. trachomatis IgG3. They tended to be nonwhite and smokers. Anti-C. trachomatis IgG3 seropositive women were significantly less likely to conceive (risk ratio [RR] 0.65, 95% confidence interval [CI] 0.52-0.83) or to have a live birth (RR 0.59, 95% CI 0.43-0.80); these associations were weakened after adjusting for number of hysterosalpingography-documented patent tubes (RR 0.73, 95% CI 0.56-0.97) and (RR 0.73, 95% CI 0.50-1.04), respectively. Anti-C. trachomatis IgG3 seropositive women who conceived had a ×2.7 risk (95% CI 1.40-5.34) of ectopic pregnancy.Conclusion(s): Even in the presence of tubal patency, anti-C. trachomatis IgG3 seropositivity is associated with a lower likelihood of pregnancy. Anti-C. trachomatis IgG3 seropositive women have as high as 3 times the risk of ectopic pregnancy.Clinical Trial Registration Number: PPCOSII: NCT00719186 and AMIGOS: NCT01044862. [ABSTRACT FROM AUTHOR]

Unlabelled: Many clinical investigators think that the burden of Institutional Review Board (IRB) requirements has been consistently increasing over recent years, although there are few objective data describing these trends. Over a period of 7 years, the Reproductive Medicine Network observed a significant increase in the size and requirements of IRB submissions and significant variability of IRB performance in reviewing multicenter trials. These additional regulatory and administrative demands represent substantial burdens to researchers and to the IRBs themselves. It is timely to consider whether these changes better protect the interests and safety of human research participants.Clinical Trial Registration: ClinicalTrials.gov NCT00068861 and NCT00719186. [ABSTRACT FROM AUTHOR]