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

NCT07471373 · ctgov recruiting

Enrollment: 160
Start: 2026-02-27
Completion: 2028-05-01
Last updated: 2026-05-15
Has results: False
Countries: France

Conditions

EndometriosisInfertilityFemale FertilityCell Free DNAGenital MicrobiotaVaginal MicrobiotaEndometrial MicrobiotaPesticidesGut MicrobiotaEpigenetics

Tagged with

endometriosis

Interventions

Circulating DNA analysis BIOLOGICAL
Circulating DNA analysis : For this study, 2 supernumerary EDTA tubes (10mL) of blood samples will be taken as part of the infectious workup.
Vaginal microbiota analysis BIOLOGICAL
Vaginal microbiota analysis : In the study, a supernumerary vaginal sample from an endocervical smear will be taken as part of the biological workup.
Endometrial microbiota analysis BIOLOGICAL
Endometrial 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.
Intestinal microbiota analysis BIOLOGICAL
Intestinal 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.
Exposure to endocrine disruptors analysis BIOLOGICAL
Exposure 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

Eligibility criteria

Inclusion Criteria: * The "case" group will include: * All women aged 18 to 43, with confirmed endometriosis and endometriosis grade 3 or 4 as defined by the 1985 revised version of the American Society of Reproductive Medicine. * The "control" group will include: * All women aged between 18 and 43, whose infertility problem is proven male infertility and who do not have endometriosis identified by biological, genetic and clinical tests. * The following criteria will apply to both groups: * All women who have not received antibiotic treatment in the three months preceding inclusion and who are not participating in any pharmacological study. * All women who are covered under the national social security health insurance scheme. * All women who have signed a written informed consent form, thereby confirming their participation in the study after a period of free and informed reflection. Exclusion Criteria: * All women aged 44 and over. * Women who are overweight, obese or anorexic. * Women taking antibiotics 3 months prior to inclusion, or participating in a drug study. * All women under anti-GnRH treatment, pregnant or suffering from a chronic inflammatory disease such as Crohn's disease, polycystic ovary syndrome, etc. * All women whose endometriosis has not been formally confirmed by the tests offered by the Reproductive Medicine and Biology Department, CECOS de Picardie, CHU Amiens-Picardie. * All patients under guardianship, curators or safeguard of justice. * All patients who have not signed the written consent confirming their participation in the study, after a period of free and informed reflection. * Any patient who withdraws her consent for participation in the study.

License: public-domain-us · commercial use OK · attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine