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CompletedNCT04085835EVOMENSUpdated Oct 6, 2025

Evolution of Menstruation

An observational study in Menstruation, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
21
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Menstruation

Keywords

  • endometrium
  • comparative genomics
03

In context

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy female volunteers experiencing regular periods

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
21 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Gene expression levels measured by RNA-seq

    Gene expression levels measured in the different cell types of the endometrial tissue during menstruation using RNA extraction and sequencing (RNA-seq)

    Time frame: Average to study completion 30 months

  2. Active regulatory elements profiled by ATAC-seq

    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

    Time frame: Average to study completion 30 months

07

Study locations

1 site
  • Institut de Biologie de l'Ecole Normale Superieure
    Paris, Île-de-France Region 75005, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04085835
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Sep 11, 2019
Start date
Oct 27, 2020
Primary completion
Apr 27, 2025
Completion
Apr 27, 2025
Last update
Oct 6, 2025

Study contacts

Camille Berthelot, PhD
principal investigator · Institut National de la Santé Et de la Recherche Médicale, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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