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NCT05556213 Clinical Trial

The Relation Between MiR-125b-5p and Staging of Endometriosis

Endometriosis Clinical Trial

Official title:
Estimation of Plasma Levels of MicroRNA 125b-5p and Transvaginal Ultrasonography May Spare Laparoscopy for Staging of Endometriosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05556213
Other study ID # 35617/8/22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2020
Est. completion date July 15, 2022

Study information
Verified date September 2022
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

78 endometriosis patients presented with infertility were clinically examined and the diagnosis was assured by US imaging. The study also included 11 control fertile women free of gynecological problems as a control for lab tests. Patients and controls gave blood samples for lab investigations. All patients underwent diagnostic abdominal laparoscopy under general anesthesia for disease staging. Quantitative determination of expression levels of genes of microRNA-125b-5p and 203a was conducted using qRT-PCR.

Recruitment information / eligibility
Status Completed
Enrollment 89
Est. completion date July 15, 2022
Est. primary completion date January 11, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 22 Years to 45 Years
Eligibility Inclusion Criteria: - Patients who presented clinical pictures suggestive of EM disease Exclusion Criteria: - Patients with previous pelvic or abdominal surgery that may hinder the laparoscopic examination, - patients who were suspicious of having malignancy elsewhere in the body region, - pregnant women, - patients who had diabetes mellitus, - body mass index (BMI) of >30 kg/m2, coagulopathies, and autoimmune disorders.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• laparoscopic examination
laparoscopic examination for staging of endometriosis
Diagnostic Test:
• Blood sampling
Blood sample to detect endometriosis

Locations
Country Name City State
Egypt Tanta university Tanta El-Gharbyia

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validity of Plasma expression level the diagnostic validity of estimation of plasma expression levels of MiR-125b-5p and 203a for diagnosis and staging of endometriosis. two weeks
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