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

NCT07586488 | Completed

• 1 other identifier: RC.12.3.2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group Early Endometriosis

ACTIVE COMPARATOR

This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility

Procedure: Staging Laparoscopy; Diagnostic Test: Laboratory Biomarker Assessment (Mirs and CA-125); Diagnostic Test: Transvaginal Ultrasound (TVS) Staging

Group Deep Endometriosis

ACTIVE COMPARATOR

This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility

Procedure: Staging Laparoscopy; Diagnostic Test: Laboratory Biomarker Assessment (Mirs and CA-125); Diagnostic Test: Transvaginal Ultrasound (TVS) Staging

Interventions

Staging Laparoscopy PROCEDURE

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.

Group Deep Endometriosis; Group Early Endometriosis

Laboratory Biomarker Assessment (Mirs and CA-125) DIAGNOSTIC_TEST

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).

Group Deep Endometriosis; Group Early Endometriosis

Transvaginal Ultrasound (TVS) Staging DIAGNOSTIC_TEST

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.

Group Deep Endometriosis; Group Early Endometriosis

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a clinical picture suggestive of Endometriosis (EM) disease.
• Agreement to undergo the full study protocol, including staging laparoscopy.

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Benha University

Banhā, Al Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obestitrics and gynecology

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: April 15, 2023
• Primary Completion: August 15, 2025
• Study Completion: October 15, 2025
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

EG (1)