Adding Insulin to IVF Culture Media Significantly Improve Outcome
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Adding insulin to In Vitro culture media
Sponsored by
About this trial
This is an interventional basic science trial for Infertility focused on measuring In Vitro, embryo quality, Intracytoplasmic sperm injection
Eligibility Criteria
Inclusion Criteria:
- normal responder
- PCOS
- Tubal factor infertility
- mild asthenozoospermia
Exclusion Criteria:
- patient over 40
Sites / Locations
- Banon IVF Center
- Ibnsina IVF center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
In Vitro culture media with insulin
In Vitro culture media without insulin m
Arm Description
We will add insulin to the single step culture media to monitor the embryogenesis
The embryos will be cultured in the media without insulin and compare this arm as the control arm with the interventional one.
Outcomes
Primary Outcome Measures
clinical Pregnancy rate ( % )
Secondary Outcome Measures
Blastocyst rate ( % )
Blastocyst quality rate ( % )
Full Information
NCT ID
NCT02420171
First Posted
April 14, 2015
Last Updated
July 11, 2016
Sponsor
Ibn Sina Hospital
Collaborators
Banon IVF Center Assiut, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT02420171
Brief Title
Adding Insulin to IVF Culture Media Significantly Improve Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banon IVF Center Assiut, Egypt
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential.
Detailed Description
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding insulin as a hormon and growth factor might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and yhe same culture condition but with one arm with insulin and the other is traditional one and closely monitor the outcome within the 2 arms abd record the results
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In Vitro, embryo quality, Intracytoplasmic sperm injection
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In Vitro culture media with insulin
Arm Type
Active Comparator
Arm Description
We will add insulin to the single step culture media to monitor the embryogenesis
Arm Title
In Vitro culture media without insulin m
Arm Type
No Intervention
Arm Description
The embryos will be cultured in the media without insulin and compare this arm as the control arm with the interventional one.
Intervention Type
Other
Intervention Name(s)
Adding insulin to In Vitro culture media
Intervention Description
We will add insulin for in vitro culture of human embryos
Primary Outcome Measure Information:
Title
clinical Pregnancy rate ( % )
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Blastocyst rate ( % )
Time Frame
6 months
Title
Blastocyst quality rate ( % )
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
normal responder
PCOS
Tubal factor infertility
mild asthenozoospermia
Exclusion Criteria:
patient over 40
Facility Information:
Facility Name
Banon IVF Center
City
Assiut
Country
Egypt
Facility Name
Ibnsina IVF center
City
Sohag
Country
Egypt
12. IPD Sharing Statement
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