- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05779462
ENDOMETRIOSIS - MRI (ENDO-MRI)
December 18, 2025 updated by: University Hospital, Lille
Study of Pelvic Organ Mobility by Dynamic MRI in Pelvic Endometriosis
Endometriosis is a frequent pathology with an estimated prevalence of 10% of women of childbearing age.
There is no exact correspondence between the symptoms described by the patients and the severity of the lesions, which makes clinical diagnosis difficult.
It therefore seems important to improve the complementary examinations available to make the diagnosis more precise and to better study the effectiveness of the treatments implemented.
The clinical examination and per-surgical findings of patients with deep pelvic endometriosis show a clear decrease in the mobility of the pelvic organs in relation to each other, but few studies have looked at this mobility, which could however have an implication in explaining the pathophysiology of the disease and the symptomatology of the patients, as well as in the detection of lesions preoperatively.
The persistence of hypo-mobility could also help to understand treatment failures.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chrystele RUBOD, MD,PhD
- Phone Number: 0320445962
- Email: chrystele.rubod@chru-lille.fr
Study Locations
-
-
-
Lille, France
- Recruiting
- Service de chirurgie gynécologique Hôpital Jeanne de Flandre - CHU de LILLE
-
Contact:
- CHRYSTELE RUBOD DIT GUILLET,
- Phone Number: 0320446757
- Email: chrystele.rubod@chru-lille.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The population concerns patients referred to the Lille University Hospital for suspected pelvic endometriosis
Description
Inclusion Criteria:
- Patient referred for suspected pelvic endometriosis requiring pelvic MRI
- Female, nulliparous,
- patient with signed written consent, patient with health insurance,
- patient willing to comply with all study procedures and duration
Exclusion Criteria:
- BMI > 35,
- history of hereditary collagen and elastic tissue disease,
- history of pelviperitonitis,
- history of major pelvic surgery,
- inability to receive informed information,
- inability to participate in the entire study,
- lack of social security coverage,
- refusal to sign consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with pelvic endometriosis
Patients referred for suspected pelvic endometriosis, with pelvic endometriosis on initial MRI
|
Addition of a Dynamic MRI Sequence during the MRI examination performed in routine care
|
|
patients without pelvic endometriosis
Patients referred for suspected pelvic endometriosis but without endometriosis found on diagnostic MRI.
|
Addition of a Dynamic MRI Sequence during the MRI examination performed in routine care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the mean vertical displacement (in millimeters) measured on the anterior wall of the vagina between rest and maximum pushing force during dynamic MRI
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI.
Time Frame: Baseline
|
Baseline
|
|
|
the mean vertical displacement (in millimetres) measured on the posterior wall of the vagina between rest and maximum pushing force during dynamic MRI.
Time Frame: Baseline
|
Baseline
|
|
|
the measurement of variation in mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort between the initial dynamic MRI of patients with
Time Frame: Baseline
|
Baseline
|
|
|
the statistical association between the symptoms of patients with endometriosis and the mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort during dynamic MRI.
Time Frame: Baseline
|
Initial symptoms are associated with initial dynamic MRI data and post therapeutic symptoms are associated with post-therapeutic dynamic MRI data. The symptoms of interest are dysmenorrhea, non-cyclic pelvic pain, dysuria, dychesia, transit disorders (diarrhea/constipation), and dyspareunia. |
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chrystele RUBOD, MD,PhD, University Hospital, Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
March 9, 2023
First Submitted That Met QC Criteria
March 9, 2023
First Posted (Actual)
March 22, 2023
Study Record Updates
Last Update Posted (Actual)
December 26, 2025
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022_0032
- 2022-A02135-38 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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