Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility

January 10, 2023 updated by: Amr Sharaf Eldein, Benha University

Plasma Levels of Micro RNA 203 and 210 Might Spare the Exploratory Laparoscopy in Case of un Explained Infertility With Suspected Endometriosis

The study targets to evaluate the role of estimation of plasma expression levels of gene of microRNAs 203 and 210 in helping to diagnose and grade endometriosis. The study included women with unexplained infertility and clinical picture suggestive of presence of endometriosis were divided randomly into two groups: Control and study groups. All patients underwent exploratory laparotomy for diagnosis and grading of endometriosis if present. Patients of study group gave blood samples for estimation of plasma expression levels of microRNA 203 and 210 using qRT-PCR procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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- Qalyobia
      • Banhā, El- Qalyobia, Egypt, 13511
        • Banha 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

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 30-45 years old
  • Unexplained infertility

Exclusion Criteria:

  • Presence of other causes of infertility,
  • age out of the predetermined range,
  • the presence of immune disorders,
  • maintenance on immunosuppressive drugs

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group
Study group Patients with unexplained infertility had estimated their Plasma Expression level for Gene"Micro RNA "203 & 210" by qRT-PCR followed by laparoscopic exploration
Procedure: Laparoscopic Exploration
Laparoscopic Exploration to diagnose & grade endometriosis
Diagnostic test: Estimation of Plasma Expression level of MICRO RNA 203 & 210
estimation of Plasma Expression level for Gene"Micro RNA "203 & 210" by qRT-PCR
Active Comparator: Control Group
Control group Patients with unexplained infertility underwent laparoscopy only
Procedure: Laparoscopic Exploration
Laparoscopic Exploration to diagnose & grade endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
grading of endometriosis
Time Frame: 8 months
The diagnostic performance of estimated plasma levels of microRNA for diagnosis and grading endometriosis
8 months

Collaborators and Investigators

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

Sponsor

Benha 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)

November 7, 2020

Primary Completion (Actual)

November 12, 2021

Study Completion (Actual)

March 25, 2022

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Estimate)

January 11, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 2.6.2022

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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