NCT05412771

Evolutive and Functional Bases of Menstruation in Women - 2

Bases Évolutives Et Fonctionnelles De La Menstruation Chez Les Femmes - 2

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Menstruation corresponds to the shedding of the uterine lining when fecundation has not occurred. This is a recent evolutionary innovation in primates, and the cellular and genetic changes that led to the acquisition of menstruation are not well understood. Additionally, the uterine lining is poorly characterized in humans across the menstrual cycle, which hinders both evolutionary and medically-relevant analyses. In this study, the research team are collecting uterine endometrial tissue samples from female donors undergoing uterine surgery for benign conditions, to profile gene expression and gene regulatory elements in the major cell types that compose the uterine lining during the secretive phase of the menstrual cycle. The investigators will compare this data to similar samples collected from other primates at the same time point in the female hormonal cycle. The objective is to identify genes that have acquired novel regulation and/or expression patterns and which may be involved in menstruation, as well as better characterize the cellular and molecular pathways at work in the uterine lining of women for translational medicine purposes.

Detailed description

Collection: The research team will collect endometrial biopsies or discarded tissue scraps from medical practice from 20 consenting female donors undergoing surgical hysteroscopy for benign uterine conditions. Primary objective: The research team will perform transcriptome sequencing and open chromatin profiling from the tissue samples and compare to similar data produced from non-human primates that either do or do not menstruate. They will identify and characterize genes and non-coding regulatory elements differentially used in menstruating species and involved in the evolution of menstruation. Secondary objectives: The research team will profile and characterize non-coding RNAs expressed in the human endometrium. The research team will establish 3D cell cultures (organoids) from the tissue samples for further functional validations of the primary objective.

Conditions

• Menstruation

Interventions

Type	Name	Description
PROCEDURE	Hysteroscopy	Samples will be collected from consenting patients undergoing a surgical hysteroscopy for medical purposes

Timeline

• Start date: 2022-11-23
• Primary completion: 2026-05-23
• Completion: 2027-10-25
• First posted: 2022-06-09
• Last updated: 2025-03-19

Locations

1 site across 1 country: France