Actively Recruiting
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
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying menstruation, which is the shedding of the uterine lining when pregnancy does not occur. This recent evolutionary feature in primates is not well understood at the cellular and genetic levels. The study aims to better characterize the uterine lining in women during the secretory phase of the menstrual cycle and compare findings with other primates to identify genes involved in menstruation and its evolution. The study involves collecting uterine endometrial tissue samples from 20 consenting female donors undergoing surgical hysteroscopy for benign uterine conditions such as removal of polyps or fibroids. These samples will be analyzed for gene expression and regulatory elements using transcriptome sequencing and open chromatin profiling. Researchers will also establish 3D cell cultures from the tissue for further study. Participants will provide tissue samples during medically indicated surgery between days 21 and 25 of their menstrual cycle. The research team will perform detailed molecular analyses over 18 months, including transcriptomics, open chromatin analysis, and profiling of non-coding RNAs. The study will also evaluate the structure, cell types, and gene expression in the 3D cell cultures. This research is sponsored by the Institut National de la Santé Et de la Recherche Médicale in France.
CONDITIONS
Brief Title
Evolutive and Functional Bases of Menstruation in Women - 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 50 years old
- Be menstruating at the time of participation
- Have given written consent
- Have an indication for hysteroscopy surgery for removal of a polyp, fibroid, endometrial tissue, or uterine malformation between days 21 and 25 of the menstrual cycle
- Be covered by social security
You will not qualify if you...
- Use of intrauterine contraceptive device during the study or within the previous three months
- Pregnancy at the time of collection
- Pregnancy within the three months prior to collection
- Amenorrhoea within the three months prior to collection
- Hormonal treatment within the three months prior to collection
- Participation in another clinical study within three months prior to collection
- Personal history of breast, ovarian, body, or cervical cancer
- Diagnosis of endometriosis
- Diagnosis of adenomyosis
- Diagnosis of Lynch syndrome
- Undergoing hysteroscopy for conditions not listed in inclusion criteria
- Not giving written consent
- Breastfeeding
- Body mass index (BMI) less than 18.5 or greater than 30
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of surgery
Participants undergo surgical hysteroscopy for medical reasons, during which endometrial biopsies or tissue scraps are collected for research.
1 surgical visit (in-person)
Duration - Up to 18 months
Participants' collected tissue samples are analyzed over time for transcriptome sequencing, open chromatin profiling, and 3D cell culture establishment and evaluation.
No additional visits required; analyses performed on collected samples
Trial Site Locations
Total: 1 location
1
Pitié salpétrière
Paris, France
Actively Recruiting
Research Team
C
Camille Berthelot, PhD
G
Geoffroy Canlorbe, MD
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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