ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)

NCT ID: NCT05153512

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-26

Study Completion Date

2021-12-26

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MRI

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BLOMET clinic

Paris, IDF, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François Oudet

Role: CONTACT

Phone: 0683346567

Email: [email protected]

Marie-Hélène Barba

Role: CONTACT

Email: [email protected]

Facility Contacts

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Marie Barba

Role: primary

Jean Francois OUDET

Role: backup

References

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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.

Reference Type DERIVED
PMID: 36592649 (View on PubMed)

Other Identifiers

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2018-A01354-51

Identifier Type: -

Identifier Source: org_study_id