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ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)

Sponsor
Ramsay Générale de Santé (Other)
Overall Status
Recruiting
CT.gov ID
NCT05153512
Collaborator
European Clinical Trial Experts Network (Other)
350
Enrollment
1
Location
27
Anticipated Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To date, no MRI study has been published describing the prevalence of endometriosis in adolescent girls, not even in those with significant dysmenorrhea and therefore more particularly at risk. Likewise, there are no precise data on the type of superficial or early-onset deep endometriosis that appears in adolescence. The collection of these data would allow an earlier diagnosis, because it is better documented, of endometriosis. The lesions would then be treated earlier, avoiding their development and the problems of infertility related to this pathology. The aim of this sudy is to assess the prevalence of endometriosis and its phenotypic representation in the study population consulting for dysmenorrhea with suspected endometriosis.

Condition or Disease Intervention/Treatment Phase
  • Procedure: MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging
Actual Study Start Date :
Sep 26, 2019
Actual Primary Completion Date :
Jun 26, 2020
Anticipated Study Completion Date :
Dec 26, 2021

Outcome Measures

Primary Outcome Measures

  1. Number of patient with endometriosis detected on MRI [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 20 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:

  • Patient aged between 12 and 20 years old.

  • After menarche.

  • Requiring pelvic MRI for exploration of dysmenorrhea (after or not ultrasound), in the case of patients with suspected endometriosis, or for any other reason (cyst, tumor, non-obstructive urogenital malformations), in the case of patients without symptoms clinic associated with endometriosis.

  • Patient affiliated or beneficiary of a social security scheme.

  • Patient and her legal representative, if applicable, having been informed and not opposing this research.

Exclusion Criteria:

  • Patient whose pelvic MRI is performed as part of an exploration of obstructive uterine malformations.

  • Patient claustrophobic, making it impossible to perform an MRI.

  • Contraindication to MRI: pacemaker, ferromagnetic object incompatible with MRI.

  • Pregnant, breastfeeding or parturient woman.

  • Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 BLOMET clinic Paris IDF France 75015

Sponsors and Collaborators

  • Ramsay Générale de Santé
  • European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramsay Générale de Santé
ClinicalTrials.gov Identifier:
NCT05153512
Other Study ID Numbers:
  • 2018-A01354-51
First Posted:
Dec 10, 2021
Last Update Posted:
Dec 10, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Endometriosis
Dysmenorrhea

Study Results

No Results Posted as of Dec 10, 2021