Edessy ICSI Outcome Embryo Score (EIOS) Efficacy

Phase 1

Completed

• Conditions: Infertility

• Registration Number: NCT02082288
• Lead Sponsor: Al-Azhar University

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).

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Results First Submitted: 2014-10-09
• Results First Submitted QC: 2014-10-09
• Results First Posted: 2014-10-16
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-11
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 243

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy	6 weeks	A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.

Trial Locations

Locations (1)

International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar university; 🇪🇬 Cairo, Egypt