Edessy Stem Cell Score (ESS), Endometrium, Endometrioma

Endometriosis, Ovarian Clinical Trial

Official title:

Edessy STEM CELL SCORE (ESS), Endometrium, Endometrioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103452
• Other study ID #: 17819555
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: April 1, 2014
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis, Ovarian

Intervention

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

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes