Evolutive and Functional Bases of Menstruation in Women - 2

NCT ID: NCT05412771

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2027-10-25

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Main cohort

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

Group Type: EXPERIMENTAL

Hysteroscopy

Intervention Type: PROCEDURE

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

Interventions

Hysteroscopy

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

Intervention Type: PROCEDURE

Eligibility 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

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pitié salpétrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Camille Berthelot, PhD

Role: CONTACT

camille.berthelot@pasteur.fr

+33186467946

Geoffroy Canlorbe, MD

Role: CONTACT

geoffroy.canlorbe@aphp.fr

Facility Contacts

sanson PUPH

Role: primary

Other Identifiers

2021-A02779-32

Identifier Type: REGISTRY

Identifier Source: secondary_id

C21-20

Identifier Type: -

Identifier Source: org_study_id