EndometriosisPOPENDONCT06973603
Exposure to Persistent Organic Pollutants and Severity of Endometriosis in the ComPaRe-Endometriosis Cohort
An observational study of Endometriosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Blood samples
- How many people
- 650 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2026to Dec 2026
- Phase
- Observational
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be a group of female volunteers who have self-reported endometriosis. The group size will be a random sample of 650 women from the ~10,000 participants included in the ComPaRe-Endometriosis sub-cohort.
Who may be able to join
- 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.
Who cannot join
- - 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
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- People suffering from any of the following diseases:
- Cancer
- Morbid obesity (BMI>40)
- Non-alcoholic steatohepatitis (NASH)
- Persons under court protection/guardianship/guardianship will not be able to participate in this research.
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
Hôpital Paris Saint Joseph
Paris, 75014
Frédérique Perrotte, IP, 01 44 12 38 31, fperrotte@ghpsj.fr
About this study
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.
- Conditions
- Endometriosis
- Being tested
- Blood samples
- Keywords
- exposition, Endometriosis, Organic Persistent Polluant, Endometriosis severity, endomestriosis symptoms, endometriosis pain
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
24mL blood sample (3 dry tubes with 8mL)
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the severity of endometriosis, defined by the type of disease.
Analysis of several online questionnaires on endometriosis by participants
Measured: During 3 last years of analysis
Evaluation of serum levels of polychlorinated biphenyls (PCBs)
Chemical analysis of participants' blood samples by the LABERCA laboratory
Measured: 5 months after inclusion start until analysis of the last participant' blood sample
Evaluation of serum levels of per- and polyfluoroalkylates (PFAS)
Chemical analysis of participants' blood samples by the LABERCA laboratory
Measured: 5 months after inclusion start until analysis of the last participant' blood sample
Evaluation of serum levels of Brominated flame retardants polluent (BFRs)
Chemical analysis of participants' blood samples by the LABERCA laboratory
Measured: 5 months after inclusion start until analysis of the last participant' blood sample
Evaluation of serum levels of organochlorine pesticides (POCs)
Chemical analysis of participants' blood samples by the LABERCA laboratory
Measured: 5 months after inclusion start until analysis of the last participant' blood sample
Secondary outcomes (3)
definition of the level of severity of endometriosis by the rASRM stage (revised stage of the American Society for Reproductive Medicine)
Analysis of online questionnaires on endometriosis and rASRM stage
Measured: During 3 last years of analysis
definition of the level of severity of endometriosis by the anatomical extension of the disease observed on MRI
Pelvic MRI images will be reviewed by radiologists from Hôpital Paris Saint Joseph to map endometriosis across 21 anatomical structures within 5 pelvic segments, using the ENZIAN classification to assess lesion location and severity.
Measured: During 3 last years of analysis
endometriosis severity level defined by the severity of painful symptoms.
Analysis of annual follow-up questionnaire of ComPaRe-Endometriosis study participant assessing the severity of various pain types over the past three months using a numeric rating scale.
Measured: During 3 last years of analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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 Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- MARINA Kvaskoff, Dr, Study director, Hôpital Paul Brousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973603
- Sponsor's protocol ID
- C24-04
- Other IDs
- ID-RCB
- Acronym
- POPENDO
- Status last verified
- Sep 2026
- First submitted
- 7 May 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided