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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05556213
• Other study ID #: 35617/8/22
• Status: Completed
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: September 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 15, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• laparoscopic examination
laparoscopic examination for staging of endometriosis

Diagnostic Test:
• Blood sampling
Blood sample to detect endometriosis

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta	El-Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two weeks