NCT04085835

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

September 5, 2019

Last Update Submit

October 1, 2025

Conditions

Menstruation

Keywords

endometriumcomparative genomics

Outcome Measures

Primary Outcomes (2)

  • 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)

    Average to study completion 30 months

  • 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

    Average to study completion 30 months

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy female volunteers experiencing regular periods

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Biologie de l'Ecole Normale Superieure

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Uterine lining (endometrium) samples obtained from menstrual fluid

Study Officials

  • Camille Berthelot, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 11, 2019

Study Start

October 27, 2020

Primary Completion

April 27, 2025

Study Completion

April 27, 2025

Last Updated

October 6, 2025

Record last verified: 2025-09

Locations

FR(1)