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

NCT07471373 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-15

No results posted yet for this study

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

  • Endometriosis
  • Infertility
  • Female Fertility
  • Cell Free DNA
  • Genital Microbiota
  • Vaginal Microbiota
  • Endometrial Microbiota
  • Pesticides
  • Gut Microbiota
  • Epigenetics

Interventions

BIOLOGICAL

Circulating DNA analysis

Circulating DNA analysis : For this study, 2 supernumerary EDTA tubes (10mL) of blood samples will be taken as part of the infectious workup.

BIOLOGICAL

Vaginal microbiota analysis

Vaginal microbiota analysis : In the study, a supernumerary vaginal sample from an endocervical smear will be taken as part of the biological workup.

BIOLOGICAL

Endometrial microbiota analysis

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.

BIOLOGICAL

Intestinal microbiota analysis

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.

BIOLOGICAL

Exposure to endocrine disruptors analysis

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-27
Primary Completion
2028-02-29
Completion
2028-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07471373 on ClinicalTrials.gov