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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

About this trial

This is an interventional supportive care trial for Infertility focused on measuring ICSI outcome

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

NCT ID

NCT02082288

First Posted

March 4, 2014

Last Updated

January 11, 2015

Sponsor

Al-Azhar University

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

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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