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RecruitingNCT07471373

Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
160 (estimated)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
Female
Age
18 Years – 43 Years
Healthy volunteers
Accepted

Summary

This project PestiEndoMicro aims to provide an innovative approach, studying endometriosis under the genital and gut microbiota scope. To realize this project, the investigators are planning to dose cfDNA to assess the oxidative stress caused by endometriosis and study its epigenetics. At the same time, the investigators will take a pragmatic approach by assessing pesticide exposure in these patients and estimate the correlation between gut or genital dysbiosis and chemical agent exposure. Also, the investigators will take the initiative to use classic culture, qPCR techniques, and NGS to establish signatures in vaginal, endometrial and gut microbiota in patients with endometriosis. With these approaches, the goal is to gain more knowledge about endometriosis and optimize early diagnosis by establishing a signature in the genital and gut microbiota, but also by dosing the cfDNA. By doing so the investigators could open new opportunities to develop new therapeutic strategies for endometriosis.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCirculating DNA analysisCirculating DNA analysis : For this study, 2 supernumerary EDTA tubes (10mL) of blood samples will be taken as part of the infectious workup.
BIOLOGICALVaginal microbiota analysisVaginal microbiota analysis : In the study, a supernumerary vaginal sample from an endocervical smear will be taken as part of the biological workup.
BIOLOGICALEndometrial microbiota analysisEndometrial microbiota analysis : As part of the study, an endometrial sample from a uterine rinse will be required. This flushing is a medical procedure performed outside the standard infertility or MAP management procedure and will only be carried out by a gynecologist once the patient has been included in the study and written consent has been received from the patient.
BIOLOGICALIntestinal microbiota analysisIntestinal microbiota analysis (secondary objective): As part of the study, a fecal sample from a patient will be required. This donation is a voluntary act on the part of the patient, outside the standard procedure for infertility treatment or MAP, and will be requested after the patient has been informed of the purpose of the procedure. Once the SHIME has been inoculated, patient donation will be no longer necessary and won't be requested from subsequent patients.
BIOLOGICALExposure to endocrine disruptors analysisExposure to endocrine disruptors analysis (secondary objective): The patient will be asked to donate a hair sample. This donation is a non-medical act performed outside the standard procedure for infertility management or MAP. In addition to hair sampling, a questionnaire on household characteristics, environment and possible exposure to endocrine disruptors will be given

Timeline

Start date
2026-02-27
Primary completion
2028-02-01
Completion
2028-05-01
First posted
2026-03-13
Last updated
2026-03-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07471373. Inclusion in this directory is not an endorsement.