Understanding the evolution and function of menstruation in women
Bases Évolutives Et Fonctionnelles De La Menstruation Chez Les Femmes - 2
NA · Institut National de la Santé Et de la Recherche Médicale, France · NCT05412771
This study is trying to understand how menstruation works by looking at tissue samples from women having surgery and comparing them to similar samples from primates to find out what genes are involved.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France (other gov) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05412771 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the genetic and cellular mechanisms underlying menstruation by collecting endometrial tissue samples from women undergoing surgery for benign conditions. The research team will perform transcriptome sequencing and open chromatin profiling on these samples, comparing the findings with similar data from non-human primates. The goal is to identify genes and regulatory elements that have evolved in menstruating species, providing insights into the biological processes involved in menstruation. Additionally, the study will establish 3D organoid cultures for further functional validation of the findings.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 50 who are menstruating and scheduled for hysteroscopic surgery for benign conditions.
Not a fit: Patients who have a history of certain cancers, endometriosis, or have recently been pregnant or used hormonal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could enhance our understanding of menstruation and lead to improved treatments for related reproductive health issues.
How similar studies have performed: While the specific approach of this study is novel, similar studies have successfully explored genetic factors in reproductive health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be between 18 and 50 years old. * Have mensturation at the time of their participation * Have given their written consent * Have an indication for surgery of hysteroscopy for removal of a polyp and/or fibroid and/or endometrial, endometrialctomy for presumed benign pathology and/or management of a uterine malformation, scheduled between days 21 and 25 of their menstrual cycle * Covered by social security Exclusion Criteria: * Using an intrauterine device contraceptive method during the study or within the previous three months * To be Pregnant at the time of collection * Have been pregnant in the three months prior to collection * Have had amenorrhoea in the three months prior to collection * Have received hormonal treatment within the three months prior to collection * Have participated in a clinical study within 3 months prior to collection * Have a personal history of breast, ovarian, body or cervical cancer * Have a diagnosis of endometriosis * Have a diagnosis of adenomyosis * Have a diagnosis of Lynch syndrome * Undergoing hysteroscopy for a condition other than those listed in the inclusion criteria * Women who have not given written consent * Women who are breastfeeding * Women with a body mass index (BMI) of less than 18.5 or more than 30
Where this trial is running
Paris
- Pitié salpétrière — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Camille Berthelot, PhD
- Email: camille.berthelot@pasteur.fr
- Phone: +33186467946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menstruation, endometrium, comparative genomics