NCT04481321

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,300

participants targeted

Target at P75+ for all trials

Timeline
177mo left

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
May 2006Dec 2040

Study Start

First participant enrolled

May 1, 2006

Completed
14.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
19.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2040

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2040

Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

34.1 years

First QC Date

July 17, 2020

Last Update Submit

November 17, 2025

Conditions

EndometriosisAdenomyosis

Keywords

EndometriosisAdenomyosispaininfertilitydisease progressiveness

Outcome Measures

Primary Outcomes (2)

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

    Composite outcome

    10 years

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

    10 years

Secondary Outcomes (17)

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

    1 year

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

    3 years

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

    5 years

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

    7 years

  • Delays between the onset of symptoms and post-operative or radiological histological diagnosis with specialized imaging (transvaginal ultrasound, endorectal ultrasound, magnetic resonance imagingI

    10 years

  • +12 more secondary outcomes

Study Arms (1)

Patient with benign gynaecologic disease

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

Biological: Biological/Vaccine

Interventions

Biological/VaccineBIOLOGICAL
Also known as: Peripheral blood,, Vaginal and urinary swab, Endometriosis lesions,endometrial biopsies, Myometer biopsies, Peritoneal fluid, Follicular fluid biopsies
Patient with benign gynaecologic disease

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • HIV-positive women, HBV and HCV
  • During pregnancy
  • Having a cancer diagnosis
  • Refusing to sign a consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Port Royal, hospital cochin

Paris, 75014, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

EndometriosisAdenomyosisPainInfertility

Interventions

Biological ProductsVaccines

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

  • Louis Marcellin, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Chapron, MD

CONTACT

1 58 41 19 33charles.chapron@aphp.fr

Laurence Lecomte, PhD

CONTACT

1 58 41 34 78laurence.lecomte@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

May 1, 2006

Primary Completion (Estimated)

June 1, 2040

Study Completion (Estimated)

December 1, 2040

Last Updated

November 20, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)