Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- quantification of circulating free DNA (cfDNA) between both groups
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 43 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Exposure to endocrine disruptors analysis (Biological)
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.
Intervention: Circulating DNA analysis (Biological)
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.
Intervention: Vaginal microbiota analysis (Biological)
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.
Intervention: Endometrial microbiota analysis (Biological)
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.
Intervention: Intestinal microbiota analysis (Biological)
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.
Intervention: Exposure to endocrine disruptors analysis (Biological)
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.
Intervention: Circulating DNA analysis (Biological)
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.
Intervention: Vaginal microbiota analysis (Biological)
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.
Intervention: Endometrial microbiota analysis (Biological)
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.
Intervention: Intestinal microbiota analysis (Biological)
Outcomes
Primary Outcomes
quantification of circulating free DNA (cfDNA) between both groups
Time Frame: 2 years
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.
Secondary Outcomes
- Variation of Vaginal microbiota signature between both groups(2 years)
- variation of Endometrial microbiota signature between both groups(2 years)
- variation of Endocrine disruptors exposure between both groups(2 years)
- variation of DNA methylation analysis(2 years)
- variation of Intestinal microbiota signature between both groups(2 years)