EndometriosisNCT07586488
Diagnostic Accuracy of Plasma MicroRNA 125b-5p and 141-3p for Early Endometriosis
A study testing Staging Laparoscopy, Laboratory Biomarker Assessment (Mirs and CA-125) and Transvaginal Ultrasound (TVS) Staging in people with Endometriosis, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Staging Laparoscopy, Laboratory Biomarker Assessment (Mirs and CA-125) and Transvaginal Ultrasound (TVS) Staging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2023to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with a clinical picture suggestive of Endometriosis (EM) disease.
- Agreement to undergo the full study protocol, including staging laparoscopy.
Who cannot join
- Presence of surgical scars hindering laparoscopy. Suspicion of malignancy or pregnancy. Body Mass Index (BMI) $> 30$ kg/m². Coagulopathies or autoimmune disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Endometriosis
- Being tested
- Staging Laparoscopy, Laboratory Biomarker Assessment (Mirs and CA-125), Transvaginal Ultrasound (TVS) Staging
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staging LaparoscopyProcedure or surgery
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) StagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Staging Laparoscopy; Diagnostic Test: Laboratory Biomarker Assessment (Mirs and CA-125); Diagnostic Test: Transvaginal Ultrasound (TVS) Staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start15 Apr 2023
- Primary completion15 Aug 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bassem Mohamed Talaat Abdelaziz Ali, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586488
- Sponsor's protocol ID
- RC.12.3.2023
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimated Levels of Plasma MicroRNA 125b-5p and 141-3p Enforce the Diagnostic Accuracy for Early Endometriosis: A Comparative Study Versus Laparoscopy
- ClinicalTrials.gov ID
- NCT07586488
- Acronym / sponsor ID
- RC.12.3.2023
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Early Endometriosis | Active comparator | Procedure: Staging Laparoscopy, Diagnostic Test: Laboratory Biomarker Assessment (Mirs and CA-125), Diagnostic Test: Transvaginal Ultrasound (TVS) StagingThis arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility |
| Group Deep Endometriosis | Active comparator | Procedure: Staging Laparoscopy, Diagnostic Test: Laboratory Biomarker Assessment (Mirs and CA-125), Diagnostic Test: Transvaginal Ultrasound (TVS) StagingThis arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with a clinical picture suggestive of Endometriosis (EM) disease.
- Agreement to undergo the full study protocol, including staging laparoscopy.
Key exclusion criteria (1 listed)
- Presence of surgical scars hindering laparoscopy. Suspicion of malignancy or pregnancy. Body Mass Index (BMI) $> 30$ kg/m². Coagulopathies or autoimmune disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staging LaparoscopyThis 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. | Procedure or surgery | Group Deep Endometriosis, Group Early Endometriosis |
| 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 | Group Deep Endometriosis, Group Early Endometriosis |
| Transvaginal Ultrasound (TVS) StagingPatients 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. | Diagnostic test | Group Deep Endometriosis, Group Early Endometriosis |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staging Laparoscopy, Laboratory Biomarker Assessment (Mirs and CA-125) and Transvaginal Ultrasound (TVS) Staging in people with Endometriosis, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity and Specificity of Plasma MicroRNA 125b-5p Fold Change for Differentiating Early Endometriosis (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.