Exposure to Persistent Organic Pollutants and Severity of Endometriosis in the ComPaRe-Endometrio… (NCT06973603) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Exposure to Persistent Organic Pollutants and Severity of Endometriosis in the ComPaRe-Endometriosis Cohort
France650 participantsStarted 2025-12
Plain-language summary
Endometriosis is a chronic inflammatory disease affecting \~10% of women of childbearing age. It is characterized by the presence of endometrial-like tissue outside the uterus, causing lesions and adhesions between the organs, and is often accompanied by intense pain and sometimes infertility. The four-stage classification based on the severity of lesions does not always reflect the severity of symptoms. Adenomyosis, a similar pathology, is often present in the same patients, although it is now considered distinct from endometriosis. Diagnosis usually takes a long time, with an average delay of 7 years. The cause of the disease remains unknown, but hormonal, genetic and environmental factors, such as exposure to endocrine disruptors, are suspected. Persistent organic pollutants (POPs), such as dioxins and PCBs, may influence the risk and severity of the disease. Although experimental studies suggest a link between these substances and the progression of endometriosis, epidemiological research on the subject is still limited.
The central hypothesis of the POPENDO project is that higher concentrations of persistent organic pollutants (POPs) are associated with increased severity of endometriosis. The aim of the study is to explore the associations between serum levels of four families of POPs (PCBs, organochlorine pesticides, PFAS and BFR) and endometriosis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ComPaRe participants ⩾ 18 years old. All ComPaRe participants are at least 18 years of age, so our research participants will all be adults.
* Having declared in ComPaRe that they had endometriosis
* Living in the Ile-de-France region (departments 75, 77, 78, 91, 92, 93, 94 or 95);
* Have given electronic consent stating: "By checking this box, I agree to be solicited for research outside ComPaRe"; This criterion is collected at the time of ComPaRe registration, when consent is collected. Participants can withdraw this consent at any time on their secure personal online account on the ComPaRe platform.
* Aged ≤ 45 years to avoid including premenopausal or menopausal women;
* In possession of MRI images used to diagnose their endometriosis (CD-ROM) that are no more than 5 years old;
* Enrolled in or benefiting from a social security scheme.
Exclusion Criteria:
* \- People with contraindications to blood sampling will not be included in this research:
* Known severe anemia
* Hemophilia/coagulation disorders/anticoagulant use
* People with HIV, HBV or HCV will not be included in this study due to the risk of BSE (Blood Exposure Accident).
* Based on factors that may disrupt lipid dynamics and lipid pollutants, the following individuals will not be included:
* Pregnant and breast-feeding women
* People suffering from any of the following diseases:
* Cancer
* Morbid obesity (BMI\>40)
* Non-alcoholic steatohepatitis (NASH)
* Persons under court prote…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the severity of endometriosis, defined by the type of disease.
Timeframe: During 3 last years of analysis
2
Evaluation of serum levels of polychlorinated biphenyls (PCBs)
Timeframe: 5 months after inclusion start until analysis of the last participant' blood sample
3
Evaluation of serum levels of per- and polyfluoroalkylates (PFAS)
Timeframe: 5 months after inclusion start until analysis of the last participant' blood sample
4
Evaluation of serum levels of Brominated flame retardants polluent (BFRs)
Timeframe: 5 months after inclusion start until analysis of the last participant' blood sample
5
Evaluation of serum levels of organochlorine pesticides (POCs)
Timeframe: 5 months after inclusion start until analysis of the last participant' blood sample
Trial details
NCT IDNCT06973603
SponsorInstitut National de la Santé Et de la Recherche Médicale, France