Edessy Stem Cell Score (ESS), Endometrium, Endometrioma

Not Applicable

Completed

• Conditions: Endometriosis, Ovarian
• Interventions: Procedure: Ovarian and endometrial samples

• Registration Number: NCT02103452
• Lead Sponsor: Al-Azhar University

Brief Summary

Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non endometriotic ovarian and endometrial tissues.

Detailed Description

This study was conducted on 40 women at Al-Azhar University Hospitals. They are divided into two equal groups, group 1 with ovarian endometrioma and group 2 with normal ovary. Ovarian and endometrial samples were evaluated by hematoxlin \& eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE.

Evaluation of IH parameters revealed that the most important factors for evaluating SC were arranged as score ( Edessy Stem Cell Score=ESS).

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-03
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-04-01
• Last Update Submitted: 2014-04-01
• Study First Posted: 2014-04-04
• Last Update Posted: 2014-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• 20 to 40 years and did not receive hormonal treatment for three month

Exclusion Criteria

• Diabetes mellitus, cardiovascular and kidney diseases, adenomyosis, Uterine fibroid Endometrial carcinoma and Poly cystic ovary

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ovarian endometrioma	Ovarian and endometrial samples	Ovarian and endometrial samples
normal ovary	Ovarian and endometrial samples	Ovarian and endometrial samples

Primary Outcome Measures

Name	Time	Method
Edessy Stem Cell Score (ESS)	1 week	ESS; * Intensity of stem cell marker: Negative to mild =0, Moderate =1, Strong =2; * Percentage of stained cells: 0 =0, 0-50%= 1, \>50-100% =2.; * Focality : None =0, Focal =1, Diffuse= 2; * Distribution: None= 0, Epithelial or mesenchymal= 1, Epithelial and mesenchymal= 2.; * Localization of positive stained cell: None=0, Cytoplasmic or nuclear =1, Cytoplasmic and nuclear= 2

Trial Locations

Locations (1)

Al Azhar University; 🇪🇬 Cairo, Egypt