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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; Endometriosis; Epigenetics; Gut Microbiota; Vaginal Microbiota; Pesticides; Cell Free DNA; Female Fertility; Genital Microbiota; Endometrial Microbiota
• Intervention / Treatment: Biological: Circulating DNA analysis; Biological: Vaginal microbiota analysis; Biological: Endometrial microbiota analysis; Biological: Intestinal microbiota analysis; Biological: Exposure to endocrine disruptors analysis

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moncef BENKHALIFA, Pr; Phone Number: 33+3 22 08 73 72; Email: benkhalifa.moncef@chu-amiens.fr

Study Locations

• France
  • Salouël, France
    • Recruiting
    • CHRU Amiens
    • Contact: Moncef BENKHALIFA, Pr; Phone Number: 33+3 22 08 73 72; Email: benkhalifa.moncef@chu-amiens.fr
    • Sub-Investigator: Hafida KHORSI-CAUET, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quantification of circulating free DNA (cfDNA) between both groups	The primary outcome will be the evaluation of oxidative stress by quantification of circulating free DNA (cfDNA) between patients in the control group and patients with endometriosis and will be established in ng/mL of plasma.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of Vaginal microbiota signature between both groups	Vaginal microbiota signature analysis	2 years
variation of Endometrial microbiota signature between both groups	Endometrial microbiota signature analysis	2 years
variation of Endocrine disruptors exposure between both groups	Endocrine disruptors exposure study	2 years
variation of Intestinal microbiota signature between both groups	Intestinal microbiota signature analysis	2 years
variation of DNA methylation analysis	variation of DNA methylation analysis	2 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Infertility; Endometriosis; cell free DNA; gut microbiota; epigenetics; pesticides; vaginal microbiota; Female fertility; genital microbiota; endometrial microbiota
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Endometriosis
• Other Study ID Numbers: PI2025_843_0212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No