Pesticide exposure, cell-free DNA, and gut/genital microbiome signatures in women with endometriosis
Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis
This project will test whether pesticide exposure is linked to oxidative-stress-related changes in circulating cell-free DNA and to differences in the gut and genital microbiomes in women with endometriosis and infertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Salouël) |
| Trial ID | NCT07471373 on ClinicalTrials.gov |
What this trial studies
The project will measure circulating cell-free DNA to estimate oxidative stress and explore its epigenetic features in women with advanced endometriosis. Investigators will quantify pesticide exposure and correlate chemical burden with gut and genital microbiome composition. Microbiome characterization will use culture, qPCR, and next-generation sequencing on vaginal, endometrial, and stool samples to seek reproducible signatures. The overall aim is to improve early diagnosis and identify potential targets for new therapeutic strategies based on combined exposure and microbiome markers.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–43 with confirmed stage 3–4 endometriosis or women 18–43 with male-factor infertility and no evidence of endometriosis, who have not used antibiotics in the prior three months, are covered by national health insurance, and can give informed consent.
Not a fit: Women older than 43, those who are overweight, obese, or severely underweight, recent antibiotic users, or participants in other pharmacologic studies are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could enable earlier diagnosis of endometriosis-related infertility and suggest microbiome- or exposure-targeted treatment approaches.
How similar studies have performed: Previous small studies have reported microbiome alterations in endometriosis and some associations between environmental chemicals and reproductive outcomes, but combining pesticide exposure, cfDNA oxidative-stress markers, and multi-site microbiome profiling is largely novel.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Salouël
- CHRU Amiens — Salouël, France (Recruiting)
Study contacts
- Study coordinator: Moncef BENKHALIFA, Pr
- Email: benkhalifa.moncef@chu-amiens.fr
- Phone: 33+3 22 08 73 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.