Objective To compare the efficacy of a selective progesterone receptor modulator, ulipristal acetate, and a gonadotropin-releasing hormone antagonist, linzagolix, in a case of severe uterine adenomyosis. Design Case report. Setting Private clinic and infertility research unit. Patient One patient born in 1981 who presented because of heavy menstrual bleeding, pelvic pain, and dysmenorrhea due to diffuse

Randomized-controlled trials (RCTs) and meta-analyses are the pinnacle of evidence-based medicine, enabling identification of the best available diagnostic, interventional, and therapeutic options. These tools help clinicians and policy-makers to set clinical guidelines, but they also represent a double-edged sword: the meaningfulness of RCTs and meta-analyses relies on their quality, performance,

As the first paper in this series of Views and Reviews on randomized controlled trials (RCTs), we aim to provide the basics of RCTs in infertility research. In this paper, we discuss the need and ethical considerations of large trials in infertility research and important aspects to guarantee the quality of a trial, including protocols, registrations and monitoring, issues of study design and analysis

In reproductive medicine, the needs and desires of infertility patients drive future research, with the most important outcome being live birth of a baby. Large, multicenter, randomized clinical trials are considered the best research tool to evaluate the effectiveness of medical interventions, but they can often take a long time to find definitive answers. Advances in individual participant data (IPD)

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

Donors should be advised of the number of cycles/donations that a given oocyte donor may undergo. Although existing data cannot permit conclusive recommendations, concern for the issues of safety and well-being of oocyte donors warrants consideration. This document replaces the document of the same name, previously published in 2014.

Objective To study whether patients exhibiting poor ovarian response have abnormal levels of serum insulin-like growth factor (IGF)-1 on cycle day 2 when compared with age-matched normal and high responders. Design Retrospective cohort. Setting University-based practice. Patient(s) All women between the ages of 21 and 42 years who underwent in vitro fertilization treatment cycle without estrogen pretreatment

Objective To identify novel candidate diagnostic microRNA (miRNA) markers of endometriosis by means of an unbiased search with confirmation by means of targeted polymerase chain reaction (PCR). Design Retrospective cohort. Setting University teaching hospitals. Patient(s) Women with endometriosis and control women, confirmed with the use of laparoscopy. Interventions(s) Diagnostic laparoscopy and blood

Objective To determine the molecular functions of genes exhibiting altered expression in the endometrium of women with uterine disorders affecting fertility. Design Retrospective analysis integrating case and control data from multiple cohorts with endometrium gene expression in women with uterine disorders. Setting Infertility research department affiliated with a university hospital. Patient(s) Two

Objective To investigate the placental morphology alterations and identify the clinical characteristics of women with polycystic ovary syndrome (PCOS) and their newborns. Pregnant women with PCOS (n = 12) and pregnant women without PCOS (n = 11) were recruited. Then, the placenta, maternal blood and cord blood were collected after delivery. Design Clinical observational study. Setting Not applicable

Objective To identify different microbial species in women with polycystic ovary syndrome (PCOS) and reveal a possible relationship between gut dysbiosis and pathological changes. Design Cross-sectional study. Setting Academic institution. Patient(s) Reproductive-aged women with PCOS (n = 14) and controls (n = 14) from the Centre for Reproductive Medicine. Intervention(s) Shotgun metagenomic sequencing

Objective To quantitate left ventricular mass index (LVMI) and correlate it with inflammation, insulin resistance (IR) and serum androgen levels among nonobese normotensive women with polycystic ovary syndrome (PCOS). Design Cross-sectional study Setting Tertiary care institute in North India Patients A total of 260 drug-naive women qualifying the Rotterdam 2003 criteria for diagnosis of PCOS and 250

Objective To evaluate the rate of postoperative complications between conservative surgery and segmental resection in patients with rectal endometriosis. Design Single-center retrospective study. Setting University hospital. Patient(s) A total of 232 women undergoing surgery for deep endometriosis infiltrating the rectum up to 15 cm from the anus with at least involvement of the muscularis layer, stratified

Objective To investigate the presence of viral RNA in human semen of severe-acute-respiratory syndrome coronavirus 2 (SARS-CoV-2) recovered and positive patients and to evaluate its presence and relevance on semen parameters. Design Pilot cohort study Setting University hospital Patients 34 adult males were distributed into a) patients in convalescence (patients with confirmed SARS-CoV-2 infection

OBJECTIVE To study the use of human embryonic stem cell-derived trophoblastic spheroids (BAP-EB) as human blastocyst surrogates for studying early implantation and trophoblast development. DESIGN Laboratory study. SETTING University research laboratory. PATIENT(S) Infertile in vitro fertilization patients donating endometrial aspirates and human embryonic stem cells (hESCs: VAL3 and H9/WA09). INTERVENTION(S)

OBJECTIVE To characterize the tubular environment in testicular biopsy tissues from patients with Klinefelter syndrome (KS). DESIGN Observational immunohistochemical study. SETTING Academic research unit. PATIENT(S) Males with KS and controls at different developmental time points: fetal, prepubertal, peripubertal, and adult. INTERVENTION(S) Immunohistochemical analysis of testicular biopsies samples

OBJECTIVE To evaluate the efficacy and safety of highly purified human menotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation in a population of patients predicted to be high responders. DESIGN Randomized, open-label, assessor-blinded, parallel-group, noninferiority trial. SETTING Fertility centers. PATIENT(S) A total of 620 women with serum antimüllerian

OBJECTIVE To assess the efficacy of sperm disomy rate as a predictor of preimplantation genetic screening (PGT-A) outcomes. DESIGN Retrospective cohort study. SETTING Andrology laboratory and in vitro fertilization center. PATIENT(S) All patients (n = 123) who underwent sperm fluorescence in situ hybridization and PGT-A at the China International Trust and Investment Corporation Xiangya Reproductive

OBJECTIVE To determine the relationship between steroid receptor expression and pain symptoms in endometriosis. DESIGN Cross-sectional SETTING: University Hospital PATIENT(S): Women with endometriosis (N = 92). INTERVENTION(S) Tissue samples were obtained from patients with surgically diagnosed endometriosis. MAIN OUTCOME MEASURE(S) A tissue microarray (TMA) was generated from patients with endometriosis

OBJECTIVE To evaluate if there are differences in standardized testing results at the end of third grade between children conceived with the use of in vitro fertilization (IVF) and those conceived spontaneously. DESIGN Retrospective population-based cohort. SETTING Texas public school system. PATIENT(S) Singleton and twin children 8-9 years of age who took the third-grade public school standardized

OBJECTIVE To investigate the effect of paternal body mass index (BMI) on neonatal outcomes of singletons after frozen-thawed embryo transfer (FET) cycles. DESIGN Retrospective cohort study. SETTING Tertiary-care academic medical center. PATIENT(S) A total of 7,908 singleton newborns were divided into four categories based on their paternal BMI: 284 (3.6%) infants were in the paternal underweight category

Objective To identify cell types in the male and female reproductive systems at risk of SARS-CoV-2 infection due to expression of host genes and proteins used by the virus for cell entry. Design Descriptive analysis of transcriptomic and proteomic data. Setting Academic research department and clinical diagnostic laboratory. Patients/Animals None. Focused on previously generated gene and protein expression

There has been increasing concern about compromised integrity in randomized controlled trials (RCTs) because it undermines the authority of this top-level evidence-generating method and puts patients at risk. Compromised RCTs also jeopardize the validity of systematic reviews and meta-analyses when they are included. The publication-driven research environment is responsible for the emergence of integrity

OBJECTIVE To study the association between use of protein supplements (PS) and semen quality among young men. DESIGN Cross-sectional study. SETTING Not applicable PATIENT(S): We used data from the Fetal Programming of Semen Quality (FEPOS) cohort, which is a subsample of 778 men whose mothers enrolled in the Danish National Birth Cohort 1996-2002. INTERVENTION(S) Semen samples were collected from April

OBJECTIVE To illustrate the surgical management of advanced endometriosis causing extrinsic ureteral compression. DESIGN Video description of the case, demonstration of the surgical technique, reevaluation at 14-year follow-up, and review of urogenital endometriosis. Patient provided consent for the video recording and publication. This surgical report with no identifying patient data was exempt from

The goals of a gestational surrogacy relationship are to have a healthy baby for the intended parents while maintaining the medical and psychological well-being of the gestational carrier. A successful gestational surrogacy relationship will result also in good psychosocial outcomes for the gestational carrier, intended parents, and child. Finding a gestational carrier who will achieve these goals

OBJECTIVE To analyze the effect of human papilloma virus (HPV) sperm infection on sperm parameters and in vitro fertilization (IVF) outcomes. DESIGN Systematic review and meta-analysis. SETTING Not applicable. PATIENTS Men with HPV sperm infection and couples undergoing IVF. INTERVENTIONS Searches were conducted in the following databases: Medline(R), PubMed, Embase, Web of Science, Scopos, and the

OBJECTIVE To assess whether the calculated difference in endometrial thickness from the end of the estrogen phase to the day of ET (after 6 days of P in hormonally prepared cycles) is associated with ongoing pregnancy rates in euploid frozen ETs (FETs). DESIGN An observational cohort study. SETTING Single tertiary care medical center. PATIENT(S) Ultrasound images from 234 hormonally prepared FET cycles

OBJECTIVE To study the development of children conceived from non-IVF infertility treatments consisting of gonadotropins, clomiphene, or letrozole. DESIGN Prospective cohort study. SETTING U.S. academic health centers. PATIENT(S) Children of women with polycystic ovary syndrome who conceived with letrozole (LTZ) or clomiphene (CC) in the PPCOS II study or women with unexplained infertility (AMIGOS

OBJECTIVE To assess whether academic achievement among children conceived following fertility treatment is different from that of children born to fertile women while also considering the underlying infertility. DESIGN Population-based cohort study. SETTING Denmark. PATIENT(S) The study population consisted of all 154,536 firstborn, live-born, singleton children in Denmark between 1995 and 2000 who

OBJECTIVE To compare sexual function and outcomes of quality of life of patients with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome after vaginal dilation and surgical procedures. STUDY DESIGN Cross-sectional study from January 2019 to June 2019. SETTING Tertiary teaching hospital. PATIENT(S) Women with MRKH syndrome treated with vaginal dilation (n = 88) or surgical procedures (n = 45). INTERVENTION

OBJECTIVE(S) To identify clinical predictors of future eating disorder symptoms in women with polycystic ovary syndrome (PCOS). DESIGN Prospective cohort study. SETTING University center. PATIENT(S) One hundred sixty-four women with PCOS by the Rotterdam criteria. INTERVENTION(S) Participants were characterized at a baseline visit between 2006 and 2017. A questionnaire including the validated Eating

OBJECTIVE To investigate PGRMC1-precipitating proteins in human endometrial stromal cells (ESC) to understand its role during in vitro decidualization. DESIGN Prospective observational study. SETTING Academic fertility center. PATIENT(S) Fifteen fertile oocyte donors. INTERVENTION(S) Isolated ESCs decidualized in vitro and used in pulldown assays. MAIN OUTCOME MEASURE(S) GST-PGRMC1-precipitated proteins

OBJECTIVE To explore the possible mechanism of protein kinase CK2, which participates in estrogen recruitment of endothelial progenitor cells (EPCs), and its role in the angiogenesis of endometriosis lesions. DESIGN Laboratory study. SETTING University. ANIMAL(S) BALB/c mice. INTERVENTION(S) Exposure of human endometrial stromal cells (HESCs) to estrogen and CK2 inhibitor CX-4945 and endometrial stromal

OBJECTIVE To report the first successful oocyte cryopreservation in a prepubertal girl. DESIGN Case report and review of the literature. SETTING Tertiary medical center. PATIENT(S) A 7-year-old prepubertal girl with Turner syndrome mosaicism (45,X[37]/47,XXX[15]) who underwent a novel fertility preservation procedure after fertility preservation counseling and informed decision of the parents. INTERVENTION(S)

OBJECTIVE To review tuboplasty techniques for alleviating fallopian tube blockage. DESIGN A step-by-step explanation of the techniques that comprise tuboplasty-fimbrioplasty, salpingo-ovariolysis, and salpingostomy-with surgical video footage. SETTING Academic medical center. PATIENT A 28-year-old G0 female patient with primary infertility and bilateral fallopian tube occlusion wanting to avoid in

OBJECTIVE To assess whether woman who have BRCA mutations (WBM) experience more declines in ovarian reserve after chemotherapy treatment, as it induces oocyte death by deoxyribonucleic acid (DNA) damage, and BRCA mutations result in DNA damage repair deficiency. DESIGN Longitudinal cohort study. SETTING Academic centers. PATIENT(S) The 108 evaluable women with breast cancer were stratified into those

Many papers and reviews have described the changes of the cervix during pregnancy, cervical cancer, sexually transmitted infections, and cervicovaginal microbiota. In this Views and Reviews, we focus on some specific topics in relation to the uterine cervix and infertility: early cervical cancer and fertility sparing surgery, cesarean scar defect, cervical incompetence, and cervical müllerian anomalies

This review sought to evaluate the current literature on reproductive and oncologic outcomes after fertility-sparing surgery for early stage cervical cancer (stage IA1–IB1) including cold-knife conization/simple trachelectomy, vaginal radical trachelectomy, abdominal radical trachelectomy, and laparoscopic radical trachelectomy with or without robotic assistance. A systematic review using the preferred

Around 20% of pregnant women undergo cesarean section (CS), and in most regions of the world CS rates continue to grow. There is still no clear definition of what is considered a normal physiologic aspect of a CS scar and what is abnormal. Cesarean scar defects (CSDs) should be suspected in women presenting with spotting, dysmenorrhea, pelvic pain, or infertility and a history of CS. CSDs can be visualized

Laparoscopic abdominal cerclage is emerging as the preferred treatment option for patients with refractory cervical insufficiency. Laparoscopic abdominal cerclage reduces second-trimester loss and preterm birth with success rates similar to open abdominal cerclage. Increasing evidence also suggests improved neonatal survival rates with abdominal cerclage compared with repeat vaginal cerclage in patients

The prevalence of congenital cervical agenesis or dysgenesis ranges from 1/80,000 to 1/100,000, and in about 50% of these cases it coexists with congenital vaginal agenesis. This narrative review summarizes the contemporary knowledge in the field of conservative surgical restoration of the reproductive tract. The management of congenital cervical malformations aims to [1] provide relief from the obstructive

Objective To investigate whether endometrial thickness (EMT) is associated with adverse obstetric and neonatal outcomes in fresh in vitro fertilization/intracytoplasmic sperm injection–embryo transfer (IVF/ICSI–ET) cycles. Design Retrospective cohort study. Setting University-based reproductive medical center. Patient(s) Women under the age of 42 years who underwent IVF/ICSI treatment and received

Objective To assess the timing of patency and late failure (secondary azoospermia) after vasovasostomy (VV) using standardized kinetics definitions. Design Retrospective cohort study. Setting University-affiliated hospital. Patient(s) Patients with obstructive azoospermia. Intervention(s) Vasovasostomy. Main Outcome Measure(s) Univariate and multivariate logistic regression assessed predictors of patency

Objective To evaluate the consistency and objectivity of deep neural networks in embryo scoring and making disposition decisions for biopsy and cryopreservation in comparison to grading by highly trained embryologists. Design Prospective double-blind study using retrospective data. Setting U.S.-based large academic fertility center. Patients Not applicable. Intervention(s) Embryo images (748 recorded

Objective To evaluate pregnancy outcomes following intrauterine insemination (IUI) in young women with low ovarian reserve compared to age-matched controls. Design Retrospective cohort Setting Single infertility center (July 2001–August 2018) Patient(s) Patients <35 years of age undergoing at least one IUI cycle with a documented serum anti-Müllerian hormone (AMH) level, patent fallopian tubes, and

Objective To determine factors associated with a positive patient experience (PPE) at fertility clinics. Design Cross-sectional study. Setting Not applicable. Patient(s) Female respondents to the FertilityIQ questionnaire (www.fertilityiq.com) reviewing the first or only U.S. clinic visited from July 2015 to July 2018. Intervention(s) None. Main Outcome Measure(s) PPE was defined as a score of 9 or

Objective To determine the optimal endometrial preparation protocols of frozen-thawed embryo transfer (FET) in young women with regular menstrual cycles. Design Retrospective cohort study. Setting Public fertility center. Patient(s) Infertile women with regular menstrual cycles undergoing FET. Intervention(s) Natural cycle (NC) treatment for patients with proven ovulation in previous cycles or who

Objective To evaluate the association between diminished ovarian reserve (DOR) in women at risk of recurrent pregnancy loss (RPL) using ovarian reserve tests. Design Systematic review and meta-analysis. Setting University medical schools. Patient(s) Women with a history of RPL. Intervention(s) Systematic reviews of major electronic databases (MEDLINE, EMBASE, Web of Science, and Scopus) for studies

Objective To evaluate the effects of gonadotropin-releasing hormone agonists (GnRH-a) on fertility in women with mild endometriosis who are undergoing in vitro fertilization and embryo transfer (IVF-ET) procedures. Design Prospective, randomized, controlled trial. Setting Three tertiary university hospitals. Patient(s) Four hundred infertile women with mild endometriosis, documented with laparoscopy

Objective To describe the outcome of fertility preservation (FP) using vitrified oocytes in patients with endometriosis and to determine the impact of ovarian surgery. Design Retrospective observational study. Setting University-affiliated private in vitro fertilization (IVF) center. Patient(s) Four hundred and eighty-five women with endometriosis who underwent FP from January 2007 to July 2018. Intervention(s)

Objective To investigate whether mutations in the minichromosome maintenance complex component 9 (MCM9) gene were present in 192 patients with sporadic premature ovarian insufficiency (POI) of Chinese descent. Design Genetic and functional study. Setting University-based reproductive medicine center. Patient(s) A total of 192 patients with sporadic POI and 192 control women with regular menstruation

Objective To determine whether the incidence of chromosomal abnormalities in blastocysts is higher in patients with idiopathic recurrent pregnancy loss (iRPL) who underwent preimplantation genetic testing for aneuploidy (PGT-A) than in those who underwent preimplantation genetic testing for monogenic defects (PGT-M). Design Retrospective cohort study. Setting University-affiliated reproductive center

Objective To assess the association between psychological stress and male factor infertility as well as testicular function (semen quality, serum reproductive hormones) and erectile dysfunction. Design Cross-sectional study. Setting University Hospital-based research center. Patients Men with impaired semen quality were included from infertile couples, and men with naturally conceived pregnant partners

Objective To examine whether accounting for a woman’s age and body mass index (BMI) would improve the ability of antimüllerian hormone (AMH) to distinguish between women with (cases) and without (controls) polycystic ovarian syndrome (PCOS). Design An opportunistic case-control dataset of reproductive age women having evaluations for PCOS as defined by National Institutes of Health criteria. Setting

Objective To describe the diagnosis and the management of hematometra in a patient with unicornuate uterus with noncommunicating functional horn (hemi uterus and rudimentary uterine hemicavity). Design Video case report. Setting Minimally invasive gynaecology unit. Patient(s) Sixteen-year-old nulliparous woman admitted to the gynaecologic emergency department with pelvic pain during menses. Intervention(s)

Objective To compare the changing peripheral levels of immune checkpoint proteins T-cell immunoglobulin mucin-3 (Tim-3)/galectin-9 (Gal-9), and programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) over a 9-day period after blastocyst transfer between women who did and did not conceive. Design Prospective observational study. Setting University teaching hospital. Patients(s) Fifty-one infertile

This article aims to identify the main legal and ethical issues around international surrogacy. Owing to the legal diversity and ethical background of such a globalized practice, a review of the key existing literature on these two matters has been identified and analyzed. The article also identifies and analyzes the most significant legal solutions provided by supranational jurisdictions when dealing

OBJECTIVE To assess the relationship between history of surgery for endometriosis and adverse obstetrical outcomes. DESIGN Retrospective study using prospectively recorded data. SETTING Referral center. PATIENT(S) Total of 569 women with history of surgery for endometriosis, postoperative conception, and pregnancy evolution over 22 weeks of gestation. INTERVENTIONS(S) Surgery for endometriosis. MAIN

Gestational surrogacy, made possible with the introduction of in vitro fertilization, has expanded family building options while introducing novel challenges to established legal principles involving constitutional, contract, and family law as well as duty of care and negligence. Both legislatures and courts have grappled with how to apply these sometimes-competing areas of law to protect participants