Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
Primary Purpose
Infertility
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Edessy ICSI Outcome Embryo Score
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility focused on measuring ICSI outcome
Eligibility Criteria
Inclusion Criteria:
- Age ≤ 40 years old. BMI >25 - 30 kg/m2. Have two ovaries. Regular cycles. 1st ICSI cycle. Long midluteal GnRH protocol
Exclusion Criteria:
uterine factor as a cause of female factor infertility. pelvic masses or diseases (e.g: endometriosis, fibroids, hydro- salpnix, ...). history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...).
azoospermia as a cause of male factor infertility.
Sites / Locations
- International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Edessy ICSI Outcome Embryo Score
Arm Description
ICSI
Outcomes
Primary Outcome Measures
Clinical Pregnancy
A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02082288
Brief Title
Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
Official Title
Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (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 detect outcome of intracytoplasmic sperm injection (ICSI) according to EIOS
Detailed Description
A total of 243 infertile couples underwent long GnRH agonist protocol in the ART unit, International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar University.
Embryos which reached the two cell stage at 25-27 hr were classified as EC, and the remaining as Non Early Cleavage embryos (NEC). Embryos were assessed again at 64-68 hours post-ICSI for day three embryo morphology score (Loi et al.,2008). The best two or three embryos, according to day 3 embryo morphology were transferred. Each patient was given a score according to EIOS (female age, number of retrieved oocytes, number of EC embryos, number of good quality embryos and number of embryos transferred).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ICSI outcome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
243 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Edessy ICSI Outcome Embryo Score
Arm Type
Experimental
Arm Description
ICSI
Intervention Type
Other
Intervention Name(s)
Edessy ICSI Outcome Embryo Score
Intervention Description
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)
Primary Outcome Measure Information:
Title
Clinical Pregnancy
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
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:
Age ≤ 40 years old. BMI >25 - 30 kg/m2. Have two ovaries. Regular cycles. 1st ICSI cycle. Long midluteal GnRH protocol
Exclusion Criteria:
uterine factor as a cause of female factor infertility. pelvic masses or diseases (e.g: endometriosis, fibroids, hydro- salpnix, ...). history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...).
azoospermia as a cause of male factor infertility.
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
Abd-Elnasr M Ali, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Fata, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wael M Hamed, MSc
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
Facility Information:
Facility Name
International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
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