Cohort of the Franco-European Multidisciplinary Institute of Endometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorClinique Tivoli Ducos
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal to participate
Patients under guardianship or curatorship, or deprived of liberty
Trial population
Women with deep endometriosis infiltrating the colon and / or the rectum
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
OBSERVATIONAL
Other interventionOBSERVATIONAL STUDY
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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).
Time frame
Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.2
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).
Time frame
Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.3
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).
Time frame
Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.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 taux de grossesse : the proportion of patients who achieved a pregnancy during follow-up (unit: percentage).
Time frame
Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.Secondary outcomes
1
Evaluation of digestive function
To evaluate digestive function, before and after treatment of digestive endometriosis compared to different colorectal surgery techniques in deep endometriosis
Time frame
Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.2
Evaluation of the probability of pregnancy
To evaluate the probability of pregnancy after different techniques of management of endometriosis of the ovaries, in order to assess their impact on ovarian reserve and the chances of pregnancy after treatment
Time frame
Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.3
Evaluation of the risk factor
To study the risk factors present in the patients' history and having a relationship with the appearance of different specific localizations of the disease
Time frame
Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.4
Evaluation of evolution of endometriosis
To study prospectively the evolution of endometriosis, with or without treatment, and the predictive factors for the development of severe forms and deep localizations of pelvic endometriosis
Time frame
Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov