Evolution of Menstruation (EVOMENS)

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.

Study Overview

• Status: Unknown
• Conditions: Menstruation

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Camille L Berthelot, PhD; Phone Number: +33144322375; Email: camille.berthelot@ens.fr
• Study Contact Backup: Name: Ismahane Guimiot, PhD; Phone Number: +33182533536; Email: ismahane.guimiot@inserm.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75005
      • Institut de Biologie de l'Ecole Normale Superieure
      • Contact: Camille Berthelot, PhD; Phone Number: +33144322375; Email: camille.berthelot@ens.fr
      • Contact: Hugues Roest Crollius, Prof; Phone Number: +33144322370; Email: hrc@ens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy female volunteers experiencing regular periods

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Camille Berthelot, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: endometrium; comparative genomics
• Other Study ID Numbers: C18-19; 2019-A01089-48 (Registry Identifier: INSERM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No