Evolution of Menstruation

This study examines gene expression and gene regulation in the uterine lining during menses in women, for evolutionary comparison with other primates which do or do not menstruate. Samples will be obtained by non-invasive collection of menstrual fluid from healthy donors.

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Key information

Conditions

Menstruation

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Biologie de l'Ecole Normale Superieure

Paris, Île-de-France Region, 75005, France

About this study

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 at the menstrual time point, which hinders both evolutionary and medically-relevant analyses.

In this study, the research team are collecting menstrual fluid samples from healthy female volunteers to profile gene expression and gene regulatory elements in the major cell types that compose the uterine lining during menstruation. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

having regular periods
being comfortable using silicone menstrual hygiene devices ("cup")
having giving consent in writing

Exclusion criteria

use of an internal contraception method (hormone or non-hormone based) during or within three months before the study
pregnancy during or within three months before the study
amenorrhea (absent periods) during or within three months before the study
gynaecological intervention or surgery within three months before the study
hormonal treatment during or within three months before the study
absence of written consent
breastfeeding
medical treatment during the study
low (< 18.5) or high (> 30) body mass index (BMI)

Treatment and study plan

Primary outcomes

Gene expression levels measured by RNA-seq

Time frame: Average to study completion 30 months

Gene expression levels measured in the different cell types of the endometrial tissue during menstruation using RNA extraction and sequencing (RNA-seq)
Active regulatory elements profiled by ATAC-seq

Time frame: Average to study completion 30 months

Profiling of the genetic elements accessible to transposase assays and sequencing (putative active regulatory elements; ATAC-seq) in the different cell types of endometrial tissue during menstruation

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

Evolution and Genetic Basis of Menstruation in Women

Acronym: EVOMENS

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Sep 11, 2019
Registry last updated: Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed