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

ConditionEndometriosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut National de la Santé Et de la Recherche Médicale, France

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Pregnant and breast-feeding women

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood samples

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Analysis of several online questionnaires on endometriosis by participants

Time frame
During 3 last years of analysis
2

Evaluation of serum levels of polychlorinated biphenyls (PCBs)

Chemical analysis of participants' blood samples by the LABERCA laboratory

Time frame
5 months after inclusion start until analysis of the last participant' blood sample
3

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

Chemical analysis of participants' blood samples by the LABERCA laboratory

Time frame
5 months after inclusion start until analysis of the last participant' blood sample
4

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

Chemical analysis of participants' blood samples by the LABERCA laboratory

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

Secondary outcomes

1

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

Time frame
During 3 last years of analysis
2

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.

Time frame
During 3 last years of analysis
3

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.

Time frame
During 3 last years of analysis

Other outcomes

Sponsors and contacts

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