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NCT Number: NCT06973603

Exposure to Persistent Organic Pollutants and Severity of Endometriosis in the ComPaRe-Endometriosis Cohort

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 protection/guardianship/guardianship will not be able to participate in this research.

Treatment and study plan

Blood Samples

Other

24mL blood sample (3 dry tubes with 8mL)

Primary outcomes

  1. Assessment of the severity of endometriosis, defined by the type of disease.

    Time frame: During 3 last years of analysis

    Analysis of several online questionnaires on endometriosis by participants

  2. Evaluation of serum levels of polychlorinated biphenyls (PCBs)

    Time frame: 5 months after inclusion start until analysis of the last participant' blood sample

    Chemical analysis of participants' blood samples by the LABERCA laboratory

  3. Evaluation of serum levels of per- and polyfluoroalkylates (PFAS)

    Time frame: 5 months after inclusion start until analysis of the last participant' blood sample

    Chemical analysis of participants' blood samples by the LABERCA laboratory

  4. Evaluation of serum levels of Brominated flame retardants polluent (BFRs)

    Time frame: 5 months after inclusion start until analysis of the last participant' blood sample

    Chemical analysis of participants' blood samples by the LABERCA laboratory

  5. Evaluation of serum levels of organochlorine pesticides (POCs)

    Time frame: 5 months after inclusion start until analysis of the last participant' blood sample

    Chemical analysis of participants' blood samples by the LABERCA laboratory

Secondary outcomes

  1. definition of the level of severity of endometriosis by the rASRM stage (revised stage of the American Society for Reproductive Medicine)

    Time frame: During 3 last years of analysis

    Analysis of online questionnaires on endometriosis and rASRM stage

  2. definition of the level of severity of endometriosis by the anatomical extension of the disease observed on MRI

    Time frame: During 3 last years of analysis

    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.

  3. endometriosis severity level defined by the severity of painful symptoms.

    Time frame: During 3 last years of analysis

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frédérique Perrotte, Principal investigator

CONTACT

[email protected]

01 44 12 38 31

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Acronym: POPENDO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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