Edessy ICSI Outcome Embryo Score (EIOS) Efficacy

NCT ID: NCT02082288

Last Updated: 2015-01-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Edessy ICSI Outcome Embryo Score

ICSI

Group Type EXPERIMENTAL

Edessy ICSI Outcome Embryo Score

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Edessy Mahmoud

al-azhar unversity (assuit), faculty of medicine, obstetrics and gynecology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Edessy, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Abd-Elnasr M Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Ahmed Fata, MD

Role: STUDY_DIRECTOR

Al-Azhar University

Wael M Hamed, MSc

Role: STUDY_CHAIR

Al-Azhar University

Locations

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International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar university

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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1234

Identifier Type: -

Identifier Source: org_study_id

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