Evolutive and Functional Bases of Menstruation in Women - 2 (NCT05412771) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evolutive and Functional Bases of Menstruation in Women - 2
France20 participantsStarted 2022-11-23
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be between 18 and 50 years old.
* Have mensturation at the time of their participation
* Have given their written consent
* Have an indication for surgery of hysteroscopy for removal of a polyp and/or fibroid and/or endometrial, endometrialctomy for presumed benign pathology and/or management of a uterine malformation, scheduled between days 21 and 25 of their menstrual cycle
* Covered by social security
Exclusion Criteria:
* Using an intrauterine device contraceptive method during the study or within the previous three months
* To be Pregnant at the time of collection
* Have been pregnant in the three months prior to collection
* Have had amenorrhoea 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 3 months prior to collection
* Have a personal history of breast, ovarian, body or cervical cancer
* Have a diagnosis of endometriosis
* Have a diagnosis of adenomyosis
* Have a diagnosis of Lynch syndrome
* Undergoing hysteroscopy for a condition other than those listed in the inclusion criteria
* Women who have not given written consent
* Women who are breastfeeding
* Women with a body mass index (BMI) of less than 18.5 or more than 30
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Transcriptomics
Timeframe: 18 months
2
Open chromatin analysis
Timeframe: 18 months
Trial details
NCT IDNCT05412771
SponsorInstitut National de la Santé Et de la Recherche Médicale, France