Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
1 other identifier
interventional
243
1 country
1
Brief Summary
Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI) according to EIOS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 10, 2014
CompletedResults Posted
Study results publicly available
October 16, 2014
CompletedJanuary 26, 2015
January 1, 2015
1.8 years
March 4, 2014
October 9, 2014
January 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Edessy ICSI Outcome Embryo Score
EXPERIMENTALICSI
Interventions
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)
Eligibility Criteria
You may qualify if:
- Age ≤ 40 years old. BMI \>25 - 30 kg/m2. Have two ovaries. Regular cycles. 1st ICSI cycle. Long midluteal GnRH protocol
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar university
Cairo, Cairo Governorate, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- wael mohamed hamed
- Organization
- al-azhar university
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- al-azhar unversity (assuit), faculty of medicine, obstetrics and gynecology department
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 10, 2014
Study Start
December 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
January 26, 2015
Results First Posted
October 16, 2014
Record last verified: 2015-01