search
Back to results

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

Primary Purpose

Endometriosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic examination
Blood sampling
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometriosis

Eligibility Criteria

22 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Tanta university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2022
Last Updated
September 24, 2022
Sponsor
Tanta University
search

1. Study Identification

Unique Protocol Identification Number
NCT05556213
Brief Title
The Relation Between MiR-125b-5p and Staging of Endometriosis
Official Title
Estimation of Plasma Levels of MicroRNA 125b-5p and Transvaginal Ultrasonography May Spare Laparoscopy for Staging of Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
laparoscopic examination
Intervention Description
laparoscopic examination for staging of endometriosis
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sampling
Intervention Description
Blood sample to detect endometriosis
Primary Outcome Measure Information:
Title
Validity of Plasma expression level
Description
the diagnostic validity of estimation of plasma expression levels of MiR-125b-5p and 203a for diagnosis and staging of endometriosis.
Time Frame
two weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Tanta university
City
Tanta
State/Province
El-Gharbyia
ZIP/Postal Code
13511
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs