An interventional study of Circulating DNA analysis and Vaginal microbiota analysis in Endometriosis, Infertility and Female Fertility, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to female participants aged 18 Years to 43 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Screening
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's planned enrollment of 160 is above the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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 · Biological: Vaginal microbiota analysis · Biological: Endometrial microbiota analysis · Biological: Intestinal microbiota analysis · Biological: Exposure to endocrine disruptors analysis
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 · Biological: Vaginal microbiota analysis · Biological: Endometrial microbiota analysis · Biological: Intestinal microbiota analysis · Biological: Exposure to endocrine disruptors analysis
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 : In the study, a supernumerary vaginal sample from an endocervical smear will be taken as part of the biological workup.
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 (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 (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
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.
Time frame: 2 years
Variation of Vaginal microbiota signature between both groups
Vaginal microbiota signature analysis
Time frame: 2 years
variation of Endometrial microbiota signature between both groups
Endometrial microbiota signature analysis
Time frame: 2 years
variation of Endocrine disruptors exposure between both groups
Endocrine disruptors exposure study
Time frame: 2 years
variation of Intestinal microbiota signature between both groups
Intestinal microbiota signature analysis
Time frame: 2 years
variation of DNA methylation analysis
variation of DNA methylation analysis
Time frame: 2 years
Plan to share: No
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Centre Hospitalier Universitaire, Amiens