CompletedNot Applicable

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

Egypt60 participantsStarted 2023-04-15

Plain-language 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.

Who can participate

Age range

25 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 18 months

Trial details

NCT IDNCT07586488

SponsorZagazig University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-08-15

View on ClinicalTrials.gov More Endometriosis trials