Edessy Stem Cell Score (ESS), Endometrium, Endometrioma

Edessy STEM CELL SCORE (ESS), Endometrium, Endometrioma

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

Study Overview

• Status: Completed
• Conditions: Endometriosis, Ovarian
• Intervention / Treatment: Procedure: Ovarian and endometrial samples

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ovarian endometrioma; Ovarian and endometrial samples	Procedure: Ovarian and endometrial samples; Ovarian and endometrial samples were evaluated by hematoxlin &eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE
Experimental: normal ovary; Ovarian and endometrial samples	Procedure: Ovarian and endometrial samples; Ovarian and endometrial samples were evaluated by hematoxlin &eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edessy Stem Cell Score (ESS)	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	1 week

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Mahmoud Edessy, MD, Al-Azhar University; Study Director: Hala hosni, MD, Cairo University; Study Director: Magdy Olama, MD, Al-Azhar University; Study Chair: Mohammad A Sattar, MD, Al-Azhar University; Study Chair: Ahmad Monir, MSc, Al-Azhar University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 26, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Estimate): April 4, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 17819555