Evaluation of miRNAs in Endometriosis

• Conditions: Endometriosis-related Pain; Endometriosis; Endometriosis Fertility

• Registration Number: NCT04728152
• Lead Sponsor: Groupe expert en endometriose-6 centre expert en endometriose

Brief Summary

We therefore propose a research project based on the prospective evaluation of miRNAs (blood and salivary) in patients with endometriosis diagnosed (by clinical examination and imaging) or suspected of endometriosis (clinical/radiological discordance) and in need of management in routine care (surgical or medical PMA) in the Endometriosis Expert Center Hospital.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-23
• Last Update Submitted: 2021-01-23
• Study Start: 2021-01-27
• Study First Posted: 2021-01-28
• Last Update Posted: 2021-01-28
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Patient aged 18 to 43 years old,

• Patient has dated and signed the consent form,
• Patient affiliated with the French health care system,
• Patients with formal endometriosis diagnosed by clinical examination and imaging or suspicion of endometriosis for which the diagnosis is a source of discrepancy between clinical and radiological data,
• Patient with an indication for medically assisted procreation (MAP) or surgery validated in CPR (in routine care),
• Patient who has had a pelvic MRI,
• Patient who completed the symptom and quality of life questionnaires

Exclusion Criteria

• Pregnant patient,
• Patient infected with the human immunodeficiency virus (HIV),
• Patient with significant difficulties in reading or writing the French language,
• Patient with a personal history of cancer,
• Patient unable to comply with study and/or follow-up procedures,
• Patient who has objected to the collection of her data.
• Patient participating in another clinical research study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe the evolution of miRNA expression (blood and salivary)	1 month

Secondary Outcome Measures

Name	Time	Method
To quantify the reproducibility of salivary miRNA expression over time (between the inclusion visit and the pre-therapy visit) ;	1 month
To describe (quantitatively and qualitatively) the expression of blood and salivary miRNAs in patients with suspected or actual endometriosis;	1 time
Describe the expression of miRNAs (blood and salivary) according to the presence or absence of endometriosis and according to the endometriosis phenotype ;	1 time
Describe the relationship between miRNA expression (blood and salivary) and the level of ovarian reserve, as estimated by the AMH assay in patients of childbearing age ;	1 time

Trial Locations

Locations (1)

Sofiane Bendifallah; 🇫🇷 Paris, France