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

Estimated Levels of Plasma MicroRNA 125b-5p and 141-3p Enforce the Diagnostic Accuracy for Early Endometriosis: A Comparative Study Versus Laparoscopy

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Procedure: Staging Laparoscopy; Diagnostic test: Laboratory Biomarker Assessment (Mirs and CA-125); Diagnostic test: Transvaginal Ultrasound (TVS) Staging

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Qalyoubia
    • Banhā, Al Qalyoubia, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Women with a clinical picture suggestive of Endometriosis (EM) disease.

Agreement to undergo the full study protocol, including staging laparoscopy.

Exclusion Criteria:

Presence of surgical scars hindering laparoscopy. Suspicion of malignancy or pregnancy. Body Mass Index (BMI) $> 30$ kg/m². Coagulopathies or autoimmune disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Early Endometriosis; This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility	Procedure: 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.; Diagnostic test: 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).; Diagnostic test: 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.
Active Comparator: Group Deep Endometriosis; This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility	Procedure: 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.; Diagnostic test: 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).; Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Sensitivity and Specificity of Plasma MicroRNA 125b-5p Fold Change for Differentiating Early Endometriosis	Evaluation of the diagnostic performance of plasma MicroRNA 125b-5p expression level (calculated as a fold-change relative to GAPDH using the $2^{-\Delta\Delta CT}$ method). The outcome measures the diagnostic sensitivity and specificity of this single genetic biomarker at a pre-determined cutoff point of $\ge 1.029$ to distinguish early endometriosis (laparoscopic Stages I-II) from deep endometriosis (laparoscopic Stages III-IV).	18 months

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: RC.12.3.2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No