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

Primary Purpose

Infertility Unexplained, Endometriosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic Exploration
Estimation of Plasma Expression level of MICRO RNA 203 & 210
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility Unexplained

Eligibility Criteria

30 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Banha University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study group

Control Group

Arm Description

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

Control group Patients with unexplained infertility underwent laparoscopy only

Outcomes

Primary Outcome Measures

grading of endometriosis
The diagnostic performance of estimated plasma levels of microRNA for diagnosis and grading endometriosis

Secondary Outcome Measures

Full Information

First Posted
December 26, 2022
Last Updated
January 10, 2023
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT05680350
Brief Title
Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility
Official Title
Plasma Levels of Micro RNA 203 and 210 Might Spare the Exploratory Laparoscopy in Case of un Explained Infertility With Suspected Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 7, 2020 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
March 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha 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
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control group Patients with unexplained infertility underwent laparoscopy only
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Exploration
Intervention Description
Laparoscopic Exploration to diagnose & grade endometriosis
Intervention Type
Diagnostic Test
Intervention Name(s)
Estimation of Plasma Expression level of MICRO RNA 203 & 210
Intervention Description
estimation of Plasma Expression level for Gene"Micro RNA "203 & 210" by qRT-PCR
Primary Outcome Measure Information:
Title
grading of endometriosis
Description
The diagnostic performance of estimated plasma levels of microRNA for diagnosis and grading endometriosis
Time Frame
8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Banha University
City
Banhā
State/Province
El- Qalyobia
ZIP/Postal Code
13511
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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