Search

The number of retractions of randomized clinical trials (RCTs) following post-publication allegations of misconduct is increasing. To address this issue, we aimed to establish an international multistakeholder consensus on post-publication integrity concerns related to RCTs. After prospective registration (https://osf.io/njksm), we assembled a multidisciplinary stakeholder group comprising 48 participants from 18 countries across six continents, recruited using a curated list of journal editors and snowballing. An underpinning evidence synthesis collated 89 articles related to post-publication integrity concerns. Integrity statements related to RCTs created were subjected to anonymized two-round Delphi survey. A hybrid face-to-face-online consensus development meeting was convened to consolidate the consensus. The response rates of the two Delphi survey rounds were 65% (31/48) and 67% (32/ 48), respectively. There were 101 and 41 statements in the first and second Delphi rounds, respectively. After the two Delphi rounds and the consensus development meeting, consensus was achieved on 104 statements consolidated to 84 after merging, editing, and removing duplicates. This set of statements included general aspects (n = 9), journal instructions (n = 14), editorial and peer review (n = 7), correspondence and complaints (n = 4), investigations for integrity concerns (n = 16), decisions and sanctions (n = 9), critical appraisal guidance (n = 1), systematic reviews of RCTs (n = 8), and research recommendations (n = 16). In conclusion, this international multistakeholder consensus statement aimed to underpin policies for preventing post-publication integrity concerns in RCT publications and assist in improving investigations of misconduct allegations., (© 2025 International Federation of Gynecology and Obstetrics.)

Endometriosis is histologically characterized by the displacement of endometrial tissue to extrauterine locations including the pelvic peritoneum, ovaries, and bowel. An important cause of infertility and pelvic pain, the individual and global socioeconomic burden of endometriosis is significant. Laparoscopy remains the gold standard for the diagnosis of the condition. However, the invasive nature of surgery, coupled with the lack of a laboratory biomarker for the disease, results in a mean latency of 7-11 years from onset of symptoms to definitive diagnosis. Unfortunately, the delay in diagnosis may have significant consequences in terms of disease progression. The discovery of a sufficiently sensitive and specific biomarker for the nonsurgical detection of endometriosis promises earlier diagnosis and prevention of deleterious sequelae and represents a clear research priority. In this review, we describe and discuss the current status of biomarkers of endometriosis in plasma, urine, and endometrium.

Endometriosis is associated with a range of pelvic-abdominal pain symptoms and infertility. It is a chronic disease that can have a significant impact on various aspects of women's lives, including their social and sexual relationships, work, and study. Despite several international guidelines on the management of endometriosis, there is a wide variety of clinical practice in the management of endometriosis, resulting in many women receiving delayed or suboptimal care. In this paper we discuss the possibilities and benefits of using electronic health records for clinical research in the field of endometriosis. The development of a wide range of clinical software for electronic patient records has made the registration of large datasets feasible and the integration of research files and clinical files possible. Integration of global standards on registration of endometriosis care in electronic health records could improve reporting of research data and facilitate the execution of large, multicentre randomized trials on the management of endometriosis. These highly needed trials could bring us the evidence needed for the optimisation of management of women with endometriosis.

Objective: Our knowledge about miscarriages mainly concerns pregnancies of at least 8 weeks' gestation. Information about the morphology and the genetic determinants of early aborted embryos remains limited. In addition, it is known that aneuploidies account for less than half of recurrent spontaneous abortions. We hypothesized that (recurrent) early pregnancy losses might have other genetic causes., Method: Products of conception from 51 couples with at least one previous miscarriage were collected by hystero-embryoscopy. The extracted DNA was analyzed by low resolution array comparative genomic hybridization and high resolution single nucleotide polymorphism arrays to detect aneuploidies, polyploidies, submicroscopic copy number variants or copy neutral loss of heterozygosity., Results: Chromosomal aberrations were identified in 65.6% (21/32) of miscarriages and in 89% (8/9) of anembryonic cases. Interestingly, 4/11 chromosomally euploid embryos contained regions of loss of heterozygosity >5 Mb, suggesting the miscarriages might be due to an underlying lethal recessive disease., Conclusion: Hystero-embryoscopic biopsy followed by array comparative genomic hybridization is a valuable diagnostic tool for early and recurrent miscarriages. Genome-wide high resolution single nucleotide polymorphism microarray analysis of a larger group of miscarriages could provide more insight into the genetic causes of recurrent spontaneous abortion., (© 2012 John Wiley & Sons, Ltd.)

Background: Baboon in vitro fertilization requires capacitated sperm inappropriate media. In this study, we compared the effect of baboon serum (Bas), human serum albumin (HSA) and bovine serum albumin (BSA) on baboon sperm capacitation., Methods: Five males (n = 5) were electroejaculated and 43 oocytes retrieved from super-ovulated female baboons (n = 10). Each sperm sample was assessed for initial motility and concentration before and after swim-up. For swim-up, each sperm sample was incubated separately in Biggers-Whitten-Whittingham media containing either BaS, HSA, BSA or without protein supplementation (control). After swim-up, each sperm aliquot was incubated with two to three oocytes. The number of sperm bound to the zona was evaluated after overnight incubation., Results: Sperm motility and zona binding was significantly higher after capacitation in media supplemented with BaS than in HSA or BSA or in media without protein supplementation (P < 0.05)., Conclusion: Baboon serum is superior to HSA or BSA for baboon sperm capacitation and zona binding.

Background: The Olive baboon is a popular animal model for reproductive and surgical research. The Institute of Primate Research, Nairobi, Kenya, has been using the animal for reproductive research for many years. In the baboon, compared with other smaller non-human primates, it is possible to insert uterine probes such as, catheters, curettes and other linear instruments (to cannulate cervix for uterine procedures like flushing, endometrium biopsy, embryo transfer, etc.)., Methods: However we noticed in a few animals this was difficult and problematic, particularly in some stages of the menstrual cycle, in retroverted uteri, in extensive adhesions or in some anatomically unique animals and we have developed a technique called 'Chai technique' for this purpose., Results and Conclusions: The Chai technique is unique to the baboon and not possible in human. It does not seem to cause injuries as frequently as uterine perforation and, in our experience, has been surprisingly successful.

Background: It is not known whether stress affects the prevalence of endometriosis in women. Baboons with spontaneous endometriosis may be interesting models to study the human disease. For baboons, living in captivity is a period of chronic stress without continuous exposure to pregnancy. This study was done to compare the prevalence of endometriosis between baboons recently captured in the wild and those living in captivity for several years., Methods: A diagnostic laparoscopy was performed for screening endometriosis and obtaining biopsies in 104 female baboons including animals that had been captured in the wild less than 1 year ago (n=52, Group I), primates that had been living in captivity for one to two years (n=30, Group II) and animals that had been captured for more than two years (n=22, Group III)., Results: The prevalence of clinical and biopsy-proven endometriosis in all baboons was 17% and 12%, respectively. Clinical endometriosis was found more frequently in group III (32%) than in group II (17%) or group I (11%). The prevalence of biopsy-proven endometriosis was also significantly higher in group III (27%) than in groups I and II combined (8%, p=0.03)., Conclusions: The results indicate that the prevalence of endometriosis increases with the time spent in captivity. This trend may be explained by more menstrual cycles uninterrupted by pregnancy in captive than in wild baboons, and possibly also by age-related factors or by captivity-associated stress.

Two hundred newborns delivered after decelerative antenatal fetal heart rate tracings were divided retrospectively into two groups, one that was small for gestational age (SGA) and another that was appropriately grown for gestational age (AGA). Analysis of the tests showed a lower prevalence of good long term variability in the SGA group when compared with the AGA group. In addition, fetal heart rate accelerations occurred less frequently in the SGA group, even in the presence of good long term variability.