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Diagnostic Accuracy of Plasma MicroRNA 125b-5p and 141-3p for Early Endometriosis
Sponsor: Zagazig University
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.
Official title: Estimated Levels of Plasma MicroRNA 125b-5p and 141-3p Enforce the Diagnostic Accuracy for Early Endometriosis: A Comparative Study Versus Laparoscopy
Key Details
Gender
FEMALE
Age Range
25 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-04-15
Completion Date
2025-10-15
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
Staging Laparoscopy
This is the surgical "gold standard" used for definitive diagnosis. Performed under intravenous anesthesia, the procedure involves the visual detection and description of EM lesions (size, appearance, and depth). Findings are staged from I-IV according to the revised American Society for Reproductive Medicine (ASRM) guidelines.
Laboratory Biomarker Assessment (Mirs and CA-125)
Two blood samples are drawn from each patient following their menstrual cycle. One sample is used to measure serum carbohydrate antigen (CA)-125 levels via ELISA. The second sample is used to estimate the plasma expression levels (fold change) of Mir-141-3p and Mir-125b-5p using quantitative real-time PCR (rt-PCR).
Transvaginal Ultrasound (TVS) Staging
Patients undergo pelvic imaging using a 7.5-MHz transvaginal probe. The procedure follows a standardized 5-domain US-based approach to identify specific endometriosis phenotypes and grade the severity of lesions prior to surgery.
Locations (1)
Benha University
Banhā, Al Qalyoubia, Egypt