Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT05412771

Evolutive and Functional Bases of Menstruation in Women - 2

Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2025-03-19

20

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 across the menstrual cycle, which hinders both evolutionary and medically-relevant analyses. In this study, the research team are collecting uterine endometrial tissue samples from female donors undergoing uterine surgery for benign conditions, to profile gene expression and gene regulatory elements in the major cell types that compose the uterine lining during the secretive phase of the menstrual cycle. 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, as well as better characterize the cellular and molecular pathways at work in the uterine lining of women for translational medicine purposes.

CONDITIONS

Official Title

Evolutive and Functional Bases of Menstruation in Women - 2

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 18 and 50 years old.
  • Be menstruating at the time of participation.
  • Provide written consent.
  • Have an indication for hysteroscopy surgery for removal of a polyp, fibroid, endometrial tissue, or uterine malformation scheduled between days 21 and 25 of the menstrual cycle.
  • Be covered by social security.
Not Eligible

You will not qualify if you...

  • Use an intrauterine device contraceptive method during the study or within the previous three months.
  • Be pregnant at the time of collection.
  • Have been pregnant in the three months prior to collection.
  • Have had amenorrhea in the three months prior to collection.
  • Have received hormonal treatment within the three months prior to collection.
  • Have participated in a clinical study within three months prior to collection.
  • Have a personal history of breast, ovarian, uterine body, or cervical cancer.
  • Have a diagnosis of endometriosis.
  • Have a diagnosis of adenomyosis.
  • Have a diagnosis of Lynch syndrome.
  • Undergo hysteroscopy for a condition other than those listed in the inclusion criteria.
  • Have not given written consent.
  • Are breastfeeding.
  • Have a body mass index (BMI) less than 18.5 or more than 30.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pitié salpétrière

Paris, France

Actively Recruiting

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Research Team

C

Camille Berthelot, PhD

CONTACT

G

Geoffroy Canlorbe, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Evolutive and Functional Bases of Menstruation in Women - 2 | DecenTrialz