Evolutive and Functional Bases of Menstruation in Women - 2

NCT05412771 | Recruiting

• 2 other identifiers: C21-202021-A02779-32
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menstruation

Keywords

endometrium; comparative genomics

Outcome Measures

Primary Outcomes (2)

• Transcriptomics

  Characterisation of genes involved in the evolutionary establishment of menstruation: transcriptome sequencing and identification of genes differentially expressed between menstruating and non-menstruating species in each cell type using DeSEQ analysis (FDR-corrected p-value \< 0.05)

  18 months

• Open chromatin analysis

  Characterisation of non-coding regulatory elements specifically involved in the evolutionary establishment of menstruation: open chromatin sequencing (ATAC-seq) and identification of non-coding genomic regions differentially activated between menstruating and non-menstruating species in each cell type using DeSEQ analysis (FDR-corrected p-value \< 0.05)

  18 months

Secondary Outcomes (5)

• Non-coding transcriptomics

  18 months

• 3D cell culture - establishment

  18 months

• 3D cell culture - structural evaluation

  18 months

• 3D cell culture - cell types evaluation

  18 months

• 3D cell culture - gene expression

  18 months

Study Arms (1)

Main cohort

EXPERIMENTAL

This is a single-arm study. Samples are collected from consenting donors undergoing surgery for medical purposes.

Procedure: Hysteroscopy

Interventions

Hysteroscopy PROCEDURE

Samples will be collected from consenting patients undergoing a surgical hysteroscopy for medical purposes

Main cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Pitié salpétrière

Paris, France

RECRUITING

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Camille Berthelot, PhD

CONTACT

+33186467946; camille.berthelot@pasteur.fr

Geoffroy Canlorbe, MD

CONTACT

geoffroy.canlorbe@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 9, 2022
• Study Start: November 23, 2022
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): October 25, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE

Locations

FR (1)