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Edessy ICSI Outcome Embryo Score (EIOS) Efficacy

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ClinicalTrials.gov Identifier: NCT02082288
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : October 16, 2014
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Edessy Mahmoud, Al-Azhar University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Infertility
Intervention Other: Edessy ICSI Outcome Embryo Score
Enrollment 243
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Edessy ICSI Outcome Embryo Score
Hide Arm/Group Description

Edessy ICSI Outcome Embryo Score: EIOS:

Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)

Period Title: Overall Study
Started 243
Completed 243
Not Completed 0
Arm/Group Title Edessy ICSI Outcome Embryo Score
Hide Arm/Group Description

Edessy ICSI Outcome Embryo Score: EIOS:

Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)

Overall Number of Baseline Participants 243
Hide Baseline Analysis Population Description
243 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 243 participants
30.12  (3.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants
Female
243
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Clinical Pregnancy
Hide Description A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edessy ICSI Outcome Embryo Score
Hide Arm/Group Description:

Edessy ICSI Outcome Embryo Score: EIOS:

Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)

Overall Number of Participants Analyzed 243
Measure Type: Number
Unit of Measure: participants
71
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Edessy ICSI Outcome Embryo Score
Hide Arm/Group Description

Edessy ICSI Outcome Embryo Score: EIOS:

Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)

All-Cause Mortality
Edessy ICSI Outcome Embryo Score
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Edessy ICSI Outcome Embryo Score
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Edessy ICSI Outcome Embryo Score
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: wael mohamed hamed
Organization: al-azhar university
Phone: 002-01001556162
Responsible Party: Edessy Mahmoud, Al-Azhar University
ClinicalTrials.gov Identifier: NCT02082288     History of Changes
Other Study ID Numbers: 1234
First Submitted: March 4, 2014
First Posted: March 10, 2014
Results First Submitted: October 9, 2014
Results First Posted: October 16, 2014
Last Update Posted: January 26, 2015