EndometriosisIFEMEndoNCT07243587
Cohort of the Franco-European Multidisciplinary Institute of Endometriosis
An observational study of Endometriosis and Deep Endometriosis, run by Clinique Tivoli Ducos at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Deep Endometriosis, Pelvic Pain
- What is being tested?
- OBSERVATIONAL
- How many people
- 15,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to Feb 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with deep endometriosis infiltrating the colon and / or the rectum
Who may be able to join
- 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
Who cannot join
- Refusal to participate
- Patients under guardianship or curatorship, or deprived of liberty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Tivoli Ducos
Bordeaux, 33000
Horace ROMAN, 0556116000, horace.roman@gmail.com
About this study
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.
Read the 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
- Being tested
- OBSERVATIONAL
- Keywords
- cohort, prospective
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBSERVATIONALOther
OBSERVATIONAL STUDY
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
To evaluate digestive function, before and after treatment of digestive endometriosis compared to different colorectal surgery techniques in deep endometriosis
Measured: 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
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
Measured: 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
To study the risk factors present in the patients' history and having a relationship with the appearance of different specific localizations of the disease
Measured: 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
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
Measured: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Feb 2021
- Primary completionFeb 2036 (estimated)
- Study completionFeb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Clinique Tivoli Ducos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243587
- Sponsor's protocol ID
- Cli-Tiv-01-2021
- Acronym
- IFEMEndo
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of the Franco-European Multidisciplinary Institute of Endometriosis
- ClinicalTrials.gov ID
- NCT07243587
- Acronym / sponsor ID
- IFEMEndo / Cli-Tiv-01-2021
- Conditions
- Endometriosis, Deep Endometriosis, Pelvic Pain
- Keywords
- cohort, prospective
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Clinique Tivoli DucosUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Feb 2036 (estimated)
- Study completion
- Feb 2036 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with deep endometriosis infiltrating the colon and / or the rectum
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to participate
- Patients under guardianship or curatorship, or deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBSERVATIONALOBSERVATIONAL STUDY | Other | – |
Primary outcome
Efficacity of differents treatments
Time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.
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).
Efficacity of differents treatments
Time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.
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).
Efficacity of differents treatments
Time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.
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).
Efficacity of differents treatments
Time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.
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).
4 secondary outcomes
Evaluation of digestive function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Deep Endometriosis, run by Clinique Tivoli Ducos at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Horace ROMAN (0556116000, horace.roman@ifemendo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacity of differents treatments (time frame: Each patient fills out the questionnaires at inclusion, and then at 1 year, 3 years, 5 years, 7 years, and 10 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.