Early Embryo Cleavage And Multiple Pregnancies After ICSI
Primary Purpose
Infertility
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
transfer early cleavage embryos
transfer non early cleavage embryo
Sponsored by
About this trial
This is an interventional screening trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- BMI >25 - 30 kg/m2
- Have two ovaries
- Regular cycles
- first 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, hydrosalpnix, ...)
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
transfer early cleavage embryos (EC)
transfer non early cleavage embryo (NEC)
Arm Description
transfer early cleavage embryos
transfer non early cleavage embryos
Outcomes
Primary Outcome Measures
clinical pregnancy
Secondary Outcome Measures
multiple pregnancy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02265055
Brief Title
Early Embryo Cleavage And Multiple Pregnancies After ICSI
Official Title
Early Embryo Cleavage And Multiple Pregnancies After ICSI
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
5. Study Description
Brief Summary
To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.
Detailed Description
A total of 193 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University in the period from December 2010 to September 2012, were included in this study.
The controlled ovarian hyperstimulation protocol was performed according to a long GnRH agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos, according to day 3 embryo morphology were transferred. The patients were subdivided into two subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non early cleavage embryo (NEC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transfer early cleavage embryos (EC)
Arm Type
Active Comparator
Arm Description
transfer early cleavage embryos
Arm Title
transfer non early cleavage embryo (NEC)
Arm Type
Active Comparator
Arm Description
transfer non early cleavage embryos
Intervention Type
Procedure
Intervention Name(s)
transfer early cleavage embryos
Intervention Description
transfer early cleavage embryos
Intervention Type
Procedure
Intervention Name(s)
transfer non early cleavage embryo
Primary Outcome Measure Information:
Title
clinical pregnancy
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
multiple pregnancy
Time Frame
8 weeks
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI >25 - 30 kg/m2
Have two ovaries
Regular cycles
first 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, hydrosalpnix, ...)
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, prof
Organizational Affiliation
ALAZHAR UNIVERSITY
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
abd elnasr m ali, prof
Organizational Affiliation
ALAZHAR UNIVERSITY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ahmed fata, prof
Organizational Affiliation
ALAZHAR UNIVERSITY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
wael hamed, dr
Organizational Affiliation
ALAZHAR UNIVERSITY
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Early Embryo Cleavage And Multiple Pregnancies After ICSI
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