Edessy ICSI Outcome Embryo Score (EIOS) Efficacy

Infertility Clinical Trial

Official title:

Edessy ICSI Outcome Embryo Score (EIOS) Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082288
• Other study ID #: 1234
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 4, 2014
• Last updated: January 11, 2015
• Start date: December 2010
• Est. completion date: September 2012

Study information

• Verified date: January 2015
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI) according to EIOS

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Egypt	International Islamic Center for Population Studies and Research (IICPSR), 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	Clinical Pregnancy	A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.	6 weeks	Yes