Trials / Recruiting
RecruitingNCT07471373
Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Centre Hospitalier Universitaire, Amiens · Academic / Other
- Sex
- Female
- Age
- 18 Years – 43 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2026-02-27
- Primary completion
- 2028-02-01
- Completion
- 2028-05-01
- First posted
- 2026-03-13
- Last updated
- 2026-03-13
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07471373. Inclusion in this directory is not an endorsement.