Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
Study Details
Study Description
Brief Summary
Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI) according to EIOS
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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).
Study Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Clinical Pregnancy [6 weeks]
A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar university | Cairo | Egypt |
Sponsors and Collaborators
- Al-Azhar University
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1234
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Edessy ICSI Outcome Embryo Score |
|---|---|
| Arm/Group Description | 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) |
| Period Title: Overall Study | |
| STARTED | 243 |
| COMPLETED | 243 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Edessy ICSI Outcome Embryo Score |
|---|---|
| Arm/Group Description | 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) |
| Overall Participants | 243 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
30.12
(3.51)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
243
100%
|
| Male |
0
0%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Edessy ICSI Outcome Embryo Score |
|---|---|
| Arm/Group Description | 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) |
| Measure Participants | 243 |
| Number [participants] |
71
29.2%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Edessy ICSI Outcome Embryo Score | |
| Arm/Group Description | 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) | |
All Cause Mortality |
||
| Edessy ICSI Outcome Embryo Score | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Edessy ICSI Outcome Embryo Score | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Edessy ICSI Outcome Embryo Score | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | wael mohamed hamed |
|---|---|
| Organization | al-azhar university |
| Phone | 002-01001556162 |
| wael79hamed@yahoo.com |
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