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NCT Number: NCT07586488

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

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.

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Key information

Conditions

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

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Al Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

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.

Primary outcomes

  1. Diagnostic Sensitivity and Specificity of Plasma MicroRNA 125b-5p Fold Change for Differentiating Early Endometriosis

    Time frame: 18 months

    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).

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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