NCT05779462

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 2023Jul 2026

First Submitted

Initial submission to the registry

March 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 23, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

March 9, 2023

Last Update Submit

December 18, 2025

Conditions

EndometriosisMobility LimitationDiagnosisPelvisComparative StudyMagnetic Resonance Imaging

Keywords

Endometriosis ;Mobility LimitationMagnetic Resonance Imaging, CinePelvisComparative Study

Outcome Measures

Primary Outcomes (1)

  • the mean vertical displacement (in millimeters) measured on the anterior wall of the vagina between rest and maximum pushing force during dynamic MRI

    Baseline

Secondary Outcomes (4)

  • the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI.

    Baseline

  • the mean vertical displacement (in millimetres) measured on the posterior wall of the vagina between rest and maximum pushing force during dynamic MRI.

    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

    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.

    Baseline

Study Arms (2)

patients with pelvic endometriosis

Patients referred for suspected pelvic endometriosis, with pelvic endometriosis on initial MRI

Other: Dynamic MRI Sequence

patients without pelvic endometriosis

Patients referred for suspected pelvic endometriosis but without endometriosis found on diagnostic MRI.

Other: Dynamic MRI Sequence

Interventions

Dynamic MRI SequenceOTHER

Addition of a Dynamic MRI Sequence during the MRI examination performed in routine care

patients with pelvic endometriosispatients without pelvic endometriosis

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale, nulliparous
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population concerns patients referred to the Lille University Hospital for suspected pelvic endometriosis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de chirurgie gynécologique Hôpital Jeanne de Flandre - CHU de LILLE

Lille, France

RECRUITING

MeSH Terms

Conditions

EndometriosisMobility LimitationDisease

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Chrystele RUBOD, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chrystele RUBOD, MD,PhD

CONTACT

0320445962chrystele.rubod@chru-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 22, 2023

Study Start

May 23, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations

FR(1)