ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)

NCT05153512 | Unknown

• 1 other identifier: 2018-A01354-51
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Number of patient with endometriosis detected on MRI

  1 day

Interventions

MRI PROCEDURE

Pelvic MRI without injection of contrast product and WITHOUT rectal or vaginal opacification

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

BLOMET clinic

Paris, IDF, 75015, France

RECRUITING

Related Publications (1)

• Millischer AE, Santulli P, Da Costa S, Bordonne C, Cazaubon E, Marcellin L, Chapron C. Adolescent endometriosis: prevalence increases with age on magnetic resonance imaging scan. Fertil Steril. 2023 Apr;119(4):626-633. doi: 10.1016/j.fertnstert.2022.12.039. Epub 2022 Dec 31.

  PMID: 36592649 DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

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

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 10, 2021
• Study Start: September 26, 2019
• Primary Completion: June 26, 2020
• Study Completion: December 26, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

FR (1)