ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream) (Adodream)

ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Procedure: MRI

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75015
      • Recruiting
      • BLOMET clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between 12 and 20 years-old and suffering from dysmenorrhea

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patient with endometriosis detected on MRI	1 day

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): June 26, 2020
• Study Completion (Anticipated): December 26, 2021

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Endometriosis; Dysmenorrhea
• Other Study ID Numbers: 2018-A01354-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No