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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Vaginal Microbiota; Female Fertility; Infertility; Gut Microbiota; Endometriosis; Pesticides; Genital Microbiota; Cell Free DNA; Endometrial Microbiota; Epigenetics

Treatments: Biological: Endometrial microbiota analysis; Biological: Circulating DNA analysis; Biological: Intestinal microbiota analysis; Biological: Vaginal microbiota analysis; Biological: Exposure to endocrine disruptors analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07471373

PI2025_843_0212

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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 annorexic.
• 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, curatorship 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Case group

Experimental group

Description:

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.

Treatment:

Biological: Exposure to endocrine disruptors analysis

Biological: Vaginal microbiota analysis

Biological: Intestinal microbiota analysis

Biological: Endometrial microbiota analysis

Biological: Circulating DNA analysis

Control group

Active Comparator group

Description:

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.

Treatment:

Biological: Exposure to endocrine disruptors analysis

Biological: Vaginal microbiota analysis

Biological: Intestinal microbiota analysis

Biological: Endometrial microbiota analysis

Biological: Circulating DNA analysis