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Edessy Stem Cell Score (ESS), Endometrium, Endometrioma

Primary Purpose

Endometriosis, Ovarian

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ovarian and endometrial samples
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometriosis, Ovarian

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Al Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ovarian endometrioma

normal ovary

Arm Description

Ovarian and endometrial samples

Ovarian and endometrial samples

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 26, 2014
Last Updated
April 1, 2014
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT02103452
Brief Title
Edessy Stem Cell Score (ESS), Endometrium, Endometrioma
Official Title
Edessy STEM CELL SCORE (ESS), Endometrium, Endometrioma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Ovarian

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ovarian endometrioma
Arm Type
Experimental
Arm Description
Ovarian and endometrial samples
Arm Title
normal ovary
Arm Type
Experimental
Arm Description
Ovarian and endometrial samples
Intervention Type
Procedure
Intervention Name(s)
Ovarian and endometrial samples
Intervention Description
Ovarian and endometrial samples were evaluated by hematoxlin &eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE
Primary Outcome Measure Information:
Title
Edessy Stem Cell Score (ESS)
Description
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
Time Frame
1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Edessy, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hala hosni, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Magdy Olama, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad A Sattar, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmad Monir, MSc
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
Facility Information:
Facility Name
Al Azhar University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Edessy Stem Cell Score (ESS), Endometrium, Endometrioma

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