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Clinical Trial NCT07471373 (PestiEndoMicro) for Endometriosis, Infertility, Female Fertility, Cell Free DNA, Genital Microbiota, Vaginal Microbiota, Endometrial Microbiota, Pesticides, Gut Microbiota, Epigenetics is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis (PestiEndoMicro) 160 Microbiome
Clinical Trial NCT07471373 (PestiEndoMicro) is an interventional study for Endometriosis, Infertility, Female Fertility, Cell Free DNA, Genital Microbiota, Vaginal Microbiota, Endometrial Microbiota, Pesticides, Gut Microbiota, Epigenetics that is recruiting. It started on 27 February 2026 with plans to enroll 160 participants. Led by Centre Hospitalier Universitaire, Amiens, it is expected to complete by 1 May 2028. The latest data from ClinicalTrials.gov was last updated on 13 March 2026.
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...Show More
Official Title
Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis
Conditions
EndometriosisInfertilityFemale FertilityCell Free DNAGenital MicrobiotaVaginal MicrobiotaEndometrial MicrobiotaPesticidesGut MicrobiotaEpigeneticsOther Study IDs
- PestiEndoMicro
- PI2025_843_0212
NCT ID Number
Start Date (Actual)
2026-02-27
Last Update Posted
2026-03-13
Completion Date (Estimated)
2028-05
Enrollment (Estimated)
160
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Endometriosis
Infertility
Female fertility
cell free DNA
genital microbiota
vaginal microbiota
endometrial microbiota
pesticides
gut microbiota
epigenetics
Infertility
Female fertility
cell free DNA
genital microbiota
vaginal microbiota
endometrial microbiota
pesticides
gut microbiota
epigenetics
Primary Purpose
Screening
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCase 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. | 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. 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. 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. 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 necessa...Show More 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 |
Active ComparatorControl 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. | 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. 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. 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. 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 necessa...Show More 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 2 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Variation of Vaginal microbiota signature between both groups | Vaginal microbiota signature analysis | 2 years |
variation of Endometrial microbiota signature between both groups | Endometrial microbiota signature analysis | 2 years |
variation of Endocrine disruptors exposure between both groups | Endocrine disruptors exposure study | 2 years |
variation of Intestinal microbiota signature between both groups | Intestinal microbiota signature analysis | 2 years |
variation of DNA methylation analysis | variation of DNA methylation analysis | 2 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- 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.
- 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.
Centre Hospitalier Universitaire, AmiensStudy Central Contact
Contact: Moncef BENKHALIFA, Pr, 33+3 22 08 73 72, [email protected]
1 Study Locations in 1 Countries
CHRU Amiens, Salouël, France
Moncef BENKHALIFA, Pr, Contact, 33+3 22 08 73 72, [email protected]
Hafida KHORSI-CAUET, Pr, Sub-Investigator
Recruiting