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

Sponsor
Centre Hospitalier Universitaire, Amiens
Study ID
NCT07471373
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 43 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

First listed
Mar 13, 2026
Start date
Feb 27, 2026
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
May 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Case group
    The "case" group will include: Etude : PestiEndoMic. 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.
  • Active Comparator: Control group
    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.

Primary Outcome Measure

quantification of circulating free DNA (cfDNA) between both groups [ Time Frame: 2 years ]

Central Contacts

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