Clinical and Molecular Study of Endometriosis and Adenomyosis

NCT ID: NCT04481321

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2040-12-31

Brief Summary

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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.

Detailed Description

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Endometriosis and adenomyosis are benign gynecological conditions which affect more than 10% of women, that typically cause pain and / or infertility, thereby exerting a negative impact on the patients' quality of life.

Although the pathogenesis of endometriosis and adenomyosis are controversial, both diseases are defined by the presence of endometrial tissue outside the uterine cavity. Endometriosis is a heterogeneous disease, with three phenotypes: superficial peritoneal endometriosis (SUP), ovarian endometrioma (OMA), and deep infiltrating endometriosis (DIE) The most widely accepted pathophysiological hypothesis for endometriosis is that of the implantation of ectopic endometrial cells following peritoneal reflux. Endometriosis can be associated with adenomyosis, also heterogeneous, characterized by the infiltration of endometrial tissue into the myometrium, presenting different forms: diffuse, focal or cystic.

Due to diseases heterogeneity, the diagnosis of endometriosis and adenomyosis is difficult and affected patients are subject to a long delay for appropriate management.

We hypothesize that the disease may be progressive in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions and recurrences. Furthermore, highlighting specific clinical and molecular markers would shorten the diagnostic time.

Conditions

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Endometriosis Adenomyosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with benign gynaecologic disease

Patients consulting for endometriosis, pelvic pain, abnormal uterine bleeding and/or infertility, or for a pelvic mass,

Biological/Vaccine

Intervention Type BIOLOGICAL

Interventions

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Biological/Vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Peripheral blood, Vaginal and urinary swab Endometriosis lesions,endometrial biopsies Myometer biopsies Peritoneal fluid Follicular fluid biopsies

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* HIV-positive women, HBV and HCV
* During pregnancy
* Having a cancer diagnosis
* Refusing to sign a consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louis Marcellin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Port Royal, hospital cochin

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charles Chapron, MD

Role: CONTACT

1 58 41 19 33 ext. +33

Laurence Lecomte, PhD

Role: CONTACT

1 58 41 34 78 ext. +33

Facility Contacts

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Louis Marcellin, MD, PhD

Role: primary

1 58415495 ext. +33

Other Identifiers

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NI18108

Identifier Type: -

Identifier Source: org_study_id

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