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

September 24, 2022 updated by: Ahmed Hagars, Tanta University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbyia
      • Tanta, El-Gharbyia, Egypt, 13511
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Diagnostic test: Blood sampling
Blood sample to detect endometriosis
Active Comparator: Patients
Procedure: laparoscopic examination
laparoscopic examination for staging of endometriosis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2020

Primary Completion (Actual)

January 11, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

September 24, 2022

First Submitted That Met QC Criteria

September 24, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 24, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35617/8/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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