MenstruationEVOMENSNCT04085835
Evolution of Menstruation
An observational study of Menstruation, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2020to 27 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy female volunteers experiencing regular periods
Who may be able to join
- having regular periods
- being comfortable using silicone menstrual hygiene devices ("cup")
- having giving consent in writing
Who cannot join
- 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
Show all 9Show fewer
- breastfeeding
- medical treatment during the study
- low (< 18.5) or high (> 30) body mass index (BMI)
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Biologie de l'Ecole Normale Superieure
Paris, Île-de-France Region, 75005
About this study
Official title: Evolution and Genetic Basis of Menstruation in Women
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.
- Conditions
- Menstruation
- Keywords
- endometrium, comparative genomics
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Average to study completion 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start27 Oct 2020
- Primary completion27 Apr 2025
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenstruationStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Camille Berthelot, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085835
- Sponsor's protocol ID
- C18-19
- Other IDs
- 2019-A01089-48
- Acronym
- EVOMENS
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2019
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leap K, Lepelletier A, Liorzou E, Doridot L, Brulport A, Berthelot C. Single-nucleus analysis of menstrual fluid highlights gene expression differences in epithelial cells of endometriosis donors. BMC Med. 2026 Jun 30;24(1):501. doi: 10.1186/s12916-026-05020-6.
PubMed 42381032
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution and Genetic Basis of Menstruation in Women
- ClinicalTrials.gov ID
- NCT04085835
- Acronym / sponsor ID
- EVOMENS / C18-19
- Conditions
- Menstruation
- Keywords
- endometrium, comparative genomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 27 Apr 2025 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy female volunteers experiencing regular periods
Key inclusion criteria (3 listed)
- having regular periods
- being comfortable using silicone menstrual hygiene devices ("cup")
- having giving consent in writing
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Results publication: PubMed 42381032Leap K, Lepelletier A, Liorzou E, Doridot L, Brulport A, Berthelot C. Single-nucleus analysis of menstrual fluid highlights gene expression differences in epithelial cells of endometriosis donors. BMC Med. 2026 Jun 30;24(1):501. doi: 10.1186/s12916-026-05020-6.
- Individual participant dataSharing planned: Undecided
Related trials for Menstruation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille Berthelot, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstruation, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression levels measured by RNA-seq (time frame: Average to study completion 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04085835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.