Clinical Trial

Diagnostic Accuracy of Plasma MicroRNA 125b-5p and 141-3p for Early Endometriosis

Completed
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Summary
Endometriosis (EM) is a chronic gynecological disorder characterized by distressing pain and a high risk of infertility. While exploratory laparoscopy is currently the standard for diagnosis and staging, it is an invasive surgical procedure with potential risks. There is a clinical need for non-invasive biomarkers to facilitate early detection and spare patients from unnecessary surgery. The objective of this prospective cohort study is to evaluate the accuracy of plasma levels of Mir-141-3p and Mir-125b-5p as distinguishing biomarkers for patients with early-stage endometriosis. The study protocol involves the following procedures: - Clinical Screening: Women presenting with symptoms suggestive of EM (e.g., dysmenorrhea, pelvic pain, or infertility) are evaluated using the 30-item Endometriosis Health Profile (EHP-30) questionnaire. Biomarker Estimation: Blood samples are drawn to measure serum carbohydrate antigen (CA)-125 and the plasma expression levels of Mir-141-3p and Mir-125b-5p. Imaging: All participants undergo transvaginal ultrasound (TVS) to assess disease phenotype and grade.
Trial Details
NCT Number NCT07586488
Lead Sponsor Zagazig University
Conditions Endometriosis
Enrollment 60 participants
Start Date 2023-04-15
Primary Completion 2025-08-15 (estimated)
Study Completion 2025-10-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-14