Evolution of Menstruation

Menstruation Clinical Trial

— EVOMENS  

Official title:

Evolution and Genetic Basis of Menstruation in Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04085835
• Other study ID #: C18-19
• Secondary ID: 2019-A01089-48
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2019
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Camille L Berthelot, PhD
• Phone: +33144322375
• Email: camille.berthelot[@]ens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Menstruation

Locations

Country	Name	City	State
France	Institut de Biologie de l'Ecole Normale Superieure	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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