Cohort of the Franco-European Multidisciplinary Institute of Endometriosis

NCT07243587 | Recruiting

• 1 other identifier: Cli-Tiv-01-2021
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Deep Endometriosis; Pelvic Pain

Keywords

cohort; prospective

Outcome Measures

Primary Outcomes (4)

• Efficacity of differents treatments

  The primary objective is to study the long-term efficacy of different treatments, both drug and surgical, in terms of symptom improvement: change in patient-reported symptom scores over time (unit: score on a validated symptom scale).

  Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.

• Efficacity of differents treatments

  The primary objective is to study the long-term efficacy of different treatments, both drug and surgical, in terms of quality of life: changes in quality of life scores over time (unit: points on a validated QoL questionnaire).

  Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.

• Efficacity of differents treatments

  The primary objective is to study the long-term efficacy of different treatments, both drug and surgical, in terms of recurrence rate: proportion of patients experiencing recurrence of the condition during follow-up (unit: percentage).

  Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.

• Efficacity of differents treatments

  The primary objective is to study the long-term efficacy of different treatments, both drug and surgical, in terms of taux de grossesse : the proportion of patients who achieved a pregnancy during follow-up (unit: percentage).

  Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.

Secondary Outcomes (4)

• Evaluation of digestive function

  Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.

• Evaluation of the probability of pregnancy

  Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.

• Evaluation of the risk factor

  Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.

• Evaluation of evolution of endometriosis

  Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.

Interventions

OBSERVATIONAL OTHER

OBSERVATIONAL STUDY

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with deep endometriosis infiltrating the colon and / or the rectum

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Clinique Tivoli Ducos: lead

Study Sites (1)

Clinique Tivoli Ducos

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Horace ROMAN

CONTACT

0556116000; horace.roman@ifemendo.fr

Clotilde HUET

CONTACT

0556116000; recherche@ifemendo.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: June 17, 2021
• First Posted: November 24, 2025
• Study Start: February 1, 2021
• Primary Completion (Estimated): February 1, 2036
• Study Completion (Estimated): February 1, 2036
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)