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Edessy ICSI Outcome Embryo Score (EIOS) Efficacy

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ClinicalTrials.gov Identifier: NCT02082288
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : October 16, 2014
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Edessy Mahmoud, Al-Azhar University

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

Condition or disease Intervention/treatment Phase
Infertility Other: Edessy ICSI Outcome Embryo Score Phase 1 Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
Study Start Date : December 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: Edessy ICSI Outcome Embryo Score
ICSI
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)





Primary Outcome Measures :
  1. Clinical Pregnancy [ Time Frame: 6 weeks ]
    A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082288


Locations
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Egypt
International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar university
Cairo, Egypt
Sponsors and Collaborators
Al-Azhar University
Investigators
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Principal Investigator: Mahmoud Edessy, MD Al-Azhar University
Principal Investigator: Abd-Elnasr M Ali, MD Al-Azhar University
Study Director: Ahmed Fata, MD Al-Azhar University
Study Chair: Wael M Hamed, MSc Al-Azhar University

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Responsible Party: Edessy Mahmoud, al-azhar unversity (assuit), faculty of medicine, obstetrics and gynecology department, Al-Azhar University
ClinicalTrials.gov Identifier: NCT02082288     History of Changes
Other Study ID Numbers: 1234
First Posted: March 10, 2014    Key Record Dates
Results First Posted: October 16, 2014
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Edessy Mahmoud, Al-Azhar University:
ICSI outcome

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female