Endometriosis
Conditions
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.
Interventions
PROCEDUREStaging 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_TESTLaboratory 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_TESTTransvaginal 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.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Sensitivity and Specificity of Plasma MicroRNA 125b-5p Fold Change for Differentiating Early Endometriosis | 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). |
Countries
Egypt
Outcome results
None listed