The Relation Between MiR-125b-5p and Staging of Endometri... | NCT05556213

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

NCT05556213

Sponsor

Tanta University

Status

Completed

Last Update Posted

Sep 27, 2022Actual

Enrollment

89Actual

Phase

Not Applicable

Conditions

Endometriosis

Interventions

laparoscopic examination
Blood sampling

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 12, 2020Actual

Primary Completion Date

Jan 11, 2022Actual

Completion Date

Jul 15, 2022Actual

First Submitted Date

Sep 24, 2022

First Submission Date that Met QC Criteria

Sep 24, 2022

First Posted Date

Sep 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2022

Last Update Posted Date

Sep 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients	Active Comparator		Procedure: laparoscopic examination
Control	Active Comparator		Diagnostic Test: Blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic examination	Procedure	laparoscopic examination for staging of endometriosis	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta university		Tanta	El-Gharbyia	13511	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided