Cohort of the Franco-European Multidisciplinary Institute of Endometriosis

NCT ID: NCT07243587

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2036-02-29

Brief Summary

Endometriosis is a chronic benign gynecological condition affecting 5 to 10% of women of reproductive age, often responsible for pelvic pain, digestive symptoms, and infertility, leading to a significant reduction in quality of life. Despite its high prevalence, the long-term outcomes of different medical and surgical treatments remain poorly documented.

The IFEMENDO study is a prospective, observational, single-center, non-interventional cohort conducted at the Endometriosis Center of Clinique Tivoli-Ducos in Bordeaux, France. The objective is to evaluate the long-term efficacy of various therapeutic strategies-both medical and surgical-in terms of symptom improvement, quality of life, recurrence, and fertility outcomes.

Women with histologically or radiologically confirmed pelvic endometriosis are invited to participate. Data are collected through standardized questionnaires at baseline and at 1, 3, 5, 7, and 10 years after inclusion, either via the secure NO ENDO online platform or in paper form. The study will contribute to a better understanding of the natural history of endometriosis and the long-term effectiveness of different treatment approaches, ultimately supporting improvements in clinical management and patient care.

Detailed Description

Detailed Description

The IFEMENDO study is an observational, single-center, non-interventional, prospective cohort conducted at the Endometriosis Center of Clinique Tivoli-Ducos in Bordeaux, France. The study aims to evaluate the long-term efficacy of various medical and surgical treatments for deep pelvic endometriosis in terms of symptom improvement, quality of life, recurrence rate, and fertility outcomes.

Endometriosis is a benign but chronic gynecological condition affecting 5 to 10% of women of reproductive age, most of whom are professionally active. It can cause pelvic pain of varying duration and intensity, digestive dysfunction, and infertility, leading to significant deterioration in quality of life and social well-being. Diagnosis is often delayed for several years after symptom onset, which explains the high prevalence of advanced stages and deep localizations at the time of diagnosis. Despite its frequency, the natural history of endometriosis and long-term outcomes after treatment remain poorly documented. Existing studies are mostly randomized trials with small sample sizes or retrospective series from single surgical teams, with follow-up rarely exceeding two or three years.

This study will include all women with histologically or radiologically confirmed pelvic endometriosis seen in consultation or operated on at the Endometriosis Center. After obtaining non-opposition consent, each participant will complete a baseline questionnaire including medical and surgical history, endometriosis-related symptoms, fertility status, and quality of life. In the case of surgery, the surgeon will complete a detailed form describing disease localization, surgical procedures performed, and any postoperative complications.

Participants will then be invited to complete follow-up questionnaires at 1, 3, 5, 7, and 10 years after inclusion. These follow-up questionnaires will cover the same domains: symptoms, fertility, and quality of life. Data will be collected through the secure NO ENDO online platform or, if preferred, on paper forms later transcribed into the electronic database by trained clinical research associates.

Registry Procedures and Quality Assurance

A quality assurance plan has been implemented to ensure the validity, reliability, and completeness of data collected in the registry. Data validation procedures include automated range and consistency checks at the time of data entry, as well as periodic manual reviews. Source data verification will be performed by comparing data entered in the NO ENDO system against medical records and operative reports.

Standard Operating Procedures are in place to guide all registry activities, including patient recruitment, informed consent documentation, data entry and management, monitoring, adverse event reporting, and database updates. The registry complies with French data protection regulations and the European General Data Protection Regulation.

Sample Size and Data Management

All eligible women consulting at the Endometriosis Center and meeting inclusion criteria will be invited to participate. The expected cohort size is several thousand patients, allowing robust statistical analyses over a 10-year follow-up period.

Conditions

Endometriosis; Deep Endometriosis; Pelvic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

OBSERVATIONAL

OBSERVATIONAL STUDY

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women aged >18 years
• Women with histologically or radiologically confirmed deep endometriosis (and/or) infiltrating the colon and/or rectum
• Women affiliated with the social security system

Exclusion Criteria

• Refusal to participate
• Patients under guardianship or curatorship, or deprived of liberty

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinique Tivoli Ducos

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Tivoli Ducos

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Horace ROMAN

Role: CONTACT

horace.roman@ifemendo.fr

0556116000

Clotilde HUET

Role: CONTACT

recherche@ifemendo.fr

0556116000

Facility Contacts

Horace ROMAN

Role: primary

horace.roman@gmail.com

0556116000

Other Identifiers

Cli-Tiv-01-2021

Identifier Type: -

Identifier Source: org_study_id