Health TrialsbyHealthPanel

Clinical and Molecular Study of Endometriosis and Adenomyosis

ConditionsEndometriosisAdenomyosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-42
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. We also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women of age between - 18 and 42 years old.

In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.

Having a radiological diagnosis made by a referral practitioner and/or operated in the department

Disqualifiers

HIV-positive women, HBV and HCV

During pregnancy

Having a cancer diagnosis

Refusing to sign a consent.

Trial population

Women of age between - 18 and 42 years old. * In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass. * Having a radiological diagnosis made by a referral practitioner and/or operated in the department.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biological/Vaccine

    Biological/Vaccine

Treatment groups

5,300 Participants
are divided into 1 treatment group
Group A: Patient with benign gynaecologic disease1 intervention

Trial outcomes

Primary outcomes

1

Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

Composite outcome

Time frame
10 years
2

Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient

Time frame
10 years

Secondary outcomes

1

Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

Time frame
1 year
2

Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

Time frame
3 years
3

Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

Time frame
5 years
4

Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

Time frame
7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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