EndometriosisENDO-MRINCT05779462
ENDOMETRIOSIS - MRI
An observational study of Endometriosis and Mobility Limitation, run by University Hospital, Lille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Mobility Limitation, Magnetic Resonance Imaging
- What is being tested?
- Dynamic MRI Sequence
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2023to Jul 2026
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The population concerns patients referred to the Lille University Hospital for suspected pelvic endometriosis
Who may be able to join
- 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
Who cannot join
- 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
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
Service de chirurgie gynécologique Hôpital Jeanne de Flandre - CHU de LILLE
Lille
CHRYSTELE RUBOD DIT GUILLET,, 0320446757, chrystele.rubod@chru-lille.fr
About this study
Official title: 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.
- Conditions
- Endometriosis, Mobility Limitation, Magnetic Resonance Imaging, Diagnosis, Pelvis, Comparative Study
- Being tested
- Dynamic MRI Sequence
- Keywords
- Endometriosis ;, Mobility Limitation, Magnetic Resonance Imaging, Cine, Pelvis, Comparative Study
- Medical subject headings
- Endometriosis, Mobility Limitation, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic MRI SequenceOther
Addition of a Dynamic MRI Sequence during the MRI examination performed in routine care
| Study group | Role | What they receive |
|---|---|---|
| patients with pelvic endometriosis | Patients referred for suspected pelvic endometriosis, with pelvic endometriosis on initial MRI Receives: Other: Dynamic MRI Sequence | |
| patients without pelvic endometriosis | Patients referred for suspected pelvic endometriosis but without endometriosis found on diagnostic MRI. Receives: Other: Dynamic MRI Sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean vertical displacement (in millimeters) measured on the anterior wall of the vagina between rest and maximum pushing force during dynamic MRI
Measured: Baseline
Secondary outcomes (4)
the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI.
Measured: Baseline
the mean vertical displacement (in millimetres) measured on the posterior wall of the vagina between rest and maximum pushing force during dynamic MRI.
Measured: 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
Measured: 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.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start23 May 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystele RUBOD, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779462
- Sponsor's protocol ID
- 2022_0032
- Other IDs
- 2022-A02135-38
- Acronym
- ENDO-MRI
- Status last verified
- Dec 2025
- First submitted
- 9 Mar 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pelvic Organ Mobility by Dynamic MRI in Pelvic Endometriosis
- ClinicalTrials.gov ID
- NCT05779462
- Acronym / sponsor ID
- ENDO-MRI / 2022_0032
- Conditions
- Endometriosis, Mobility Limitation, Magnetic Resonance Imaging, Diagnosis, Pelvis, Comparative Study
- Keywords
- Endometriosis ;, Mobility Limitation, Magnetic Resonance Imaging, Cine, Pelvis, Comparative Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Mar 2023 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with pelvic endometriosis | – | Other: Dynamic MRI SequencePatients referred for suspected pelvic endometriosis, with pelvic endometriosis on initial MRI |
| patients without pelvic endometriosis | – | Other: Dynamic MRI SequencePatients referred for suspected pelvic endometriosis but without endometriosis found on diagnostic MRI. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The population concerns patients referred to the Lille University Hospital for suspected pelvic endometriosis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- BMI > 35,
- history of hereditary collagen and elastic tissue disease,
- history of pelviperitonitis,
- history of major pelvic surgery,
- inability to receive informed information,
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 |
|---|---|---|
| Dynamic MRI SequenceAddition of a Dynamic MRI Sequence during the MRI examination performed in routine care | Other | patients with pelvic endometriosis, patients without pelvic endometriosis |
Primary outcome
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
4 secondary outcomes
the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI.
Time frame: 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
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
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
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 26 Dec 2025.
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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.
Chrystele RUBOD, MD,PhD principal investigator
University Hospital, Lille
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 Mobility Limitation, run by University Hospital, Lille 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 4 inclusion and 8 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 26 Dec 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 Chrystele RUBOD, MD,PhD (0320445962, chrystele.rubod@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 26 Dec 2025.