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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT05556213

Collaborator

(none)

Enrollment

Location

Arms

26.1

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Procedure: laparoscopic examination Diagnostic Test: Blood sampling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 12, 2020

Actual Primary Completion Date :

Jan 11, 2022

Actual Study Completion Date :

Jul 15, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Patients

Procedure: laparoscopic examination

laparoscopic examination for staging of endometriosis

Active Comparator: Control

Diagnostic Test: Blood sampling

Blood sample to detect endometriosis

Outcome Measures

Primary Outcome Measures

Validity of Plasma expression level [two weeks]
the diagnostic validity of estimation of plasma expression levels of MiR-125b-5p and 203a for diagnosis and staging of endometriosis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta university	Tanta	El-Gharbyia	Egypt	13511

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Hagars, Assistant professor of gynecology, Tanta University

ClinicalTrials.gov Identifier:

NCT05556213

Other Study ID Numbers:

35617/8/22

First Posted:

Sep 27, 2022

Last Update Posted:

Sep 27, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Sep 27, 2022