EndometriosisPestiEndoMicroNCT07471373
Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis
A study testing Circulating DNA analysis, Vaginal microbiota analysis and Endometrial microbiota analysis in people with Endometriosis and Infertility, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Infertility, Female Fertility
- What is being tested?
- Circulating DNA analysis, Vaginal microbiota analysis and Endometrial microbiota analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Salouël
Moncef BENKHALIFA, Pr, 33+3 22 08 73 72, benkhalifa.moncef@chu-amiens.fr
Hafida KHORSI-CAUET, Pr
About this study
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
- Being tested
- Circulating DNA analysis, Vaginal microbiota analysis, Endometrial microbiota analysis, Intestinal microbiota analysis, Exposure to endocrine disruptors analysis
- Keywords
- Endometriosis, Infertility, Female fertility, cell free DNA, genital microbiota, vaginal microbiota, endometrial microbiota, pesticides, gut microbiota, epigenetics
- Medical subject headings
- Endometriosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating DNA analysisBiological
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 analysisBiological
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 analysisBiological
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 analysisBiological
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 analysisBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | 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. Receives: Biological: Circulating DNA analysis; Biological: Vaginal microbiota analysis; Biological: Endometrial microbiota analysis; Biological: Intestinal microbiota analysis; Biological: Exposure to endocrine disruptors analysis |
| Control group | Active comparator | 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. Receives: Biological: Circulating DNA analysis; Biological: Vaginal microbiota analysis; Biological: Endometrial microbiota analysis; Biological: Intestinal microbiota analysis; Biological: Exposure to endocrine disruptors analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
Variation of Vaginal microbiota signature between both groups
Vaginal microbiota signature analysis
Measured: 2 years
variation of Endometrial microbiota signature between both groups
Endometrial microbiota signature analysis
Measured: 2 years
variation of Endocrine disruptors exposure between both groups
Endocrine disruptors exposure study
Measured: 2 years
variation of Intestinal microbiota signature between both groups
Intestinal microbiota signature analysis
Measured: 2 years
variation of DNA methylation analysis
variation of DNA methylation analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start27 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471373
- Sponsor's protocol ID
- PI2025_843_0212
- Acronym
- PestiEndoMicro
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis
- ClinicalTrials.gov ID
- NCT07471373
- Acronym / sponsor ID
- PestiEndoMicro / PI2025_843_0212
- Conditions
- Endometriosis, Infertility, Female Fertility, Cell Free DNA, Genital Microbiota, Vaginal Microbiota
- Keywords
- Endometriosis, Infertility, Female fertility, cell free DNA, genital microbiota, vaginal microbiota, endometrial microbiota, pesticides
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Biological: Circulating DNA analysis, Biological: Vaginal microbiota analysis, Biological: Endometrial microbiota analysis, Biological: Intestinal microbiota analysis, Biological: Exposure to endocrine disruptors analysisThe "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. |
| Control group | Active comparator | Biological: Circulating DNA analysis, Biological: Vaginal microbiota analysis, Biological: Endometrial microbiota analysis, Biological: Intestinal microbiota analysis, Biological: Exposure to endocrine disruptors analysisThe "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. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating DNA analysisCirculating DNA analysis : For this study, 2 supernumerary EDTA tubes (10mL) of blood samples will be taken as part of the infectious workup. | Biological | Case group, Control group |
| Vaginal microbiota analysisVaginal microbiota analysis : In the study, a supernumerary vaginal sample from an endocervical smear will be taken as part of the biological workup. | Biological | Case group, Control group |
| Endometrial microbiota analysisEndometrial 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 | Case group, Control group |
| Intestinal microbiota analysisIntestinal 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 | Case group, Control group |
| Exposure to endocrine disruptors analysisExposure 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 | Biological | Case group, Control group |
Primary outcome
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.
5 secondary outcomes
Variation of Vaginal microbiota signature between both groups
Time frame: 2 years
variation of Endometrial microbiota signature between both groups
Time frame: 2 years
variation of Endocrine disruptors exposure between both groups
Time frame: 2 years
variation of Intestinal microbiota signature between both groups
Time frame: 2 years
variation of DNA methylation analysis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circulating DNA analysis, Vaginal microbiota analysis and Endometrial microbiota analysis in people with Endometriosis and Infertility, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moncef BENKHALIFA, Pr (33+3 22 08 73 72, benkhalifa.moncef@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantification of circulating free DNA (cfDNA) between both groups (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.