Back to resultsComparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bicarbonate-buffered handling medium
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- ICSI indicated cycles
Exclusion Criteria:
- severe medical illness
Sites / Locations
- Banon Assiut
- Qena Fertility Center
- IbnSina IVF Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bicarbonate-buffered Medium
HEPES-MOPS-buffered Medium
Arm Description
Outcomes
Primary Outcome Measures
live birth rate
viable neonate after 30 weeks of Gestation
Secondary Outcome Measures
Clinical pregnancy rate
a positive heartbeat on ultrasound at ≥ 7 weeks of gestation
biochemical pregnancy rate
positive b-hCG at ≥ 14 days following embryo transfer
embryo developmental rates
fertilized oocyte per injected ones and developed embryos per fertilized oocytes
Ongoing pregnancy rate
Continued pregnancy after week 12 of gestation
Full Information
NCT ID
NCT03778866
First Posted
December 15, 2018
Last Updated
August 5, 2019
Sponsor
Muhammad Fawzy
Collaborators
Banoon IVF Center, Quena IVF Center
1. Study Identification
Unique Protocol Identification Number
NCT03778866
Brief Title
Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate
Official Title
Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Muhammad Fawzy
Collaborators
Banoon IVF Center, Quena IVF Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1057 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bicarbonate-buffered Medium
Arm Type
Experimental
Arm Title
HEPES-MOPS-buffered Medium
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Bicarbonate-buffered handling medium
Intervention Description
The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.
Primary Outcome Measure Information:
Title
live birth rate
Description
viable neonate after 30 weeks of Gestation
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
a positive heartbeat on ultrasound at ≥ 7 weeks of gestation
Time Frame
12 weeks
Title
biochemical pregnancy rate
Description
positive b-hCG at ≥ 14 days following embryo transfer
Time Frame
two weeks
Title
embryo developmental rates
Description
fertilized oocyte per injected ones and developed embryos per fertilized oocytes
Time Frame
6 days of culture
Title
Ongoing pregnancy rate
Description
Continued pregnancy after week 12 of gestation
Time Frame
16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ICSI indicated cycles
Exclusion Criteria:
severe medical illness
Facility Information:
Facility Name
Banon Assiut
City
Assiut
Country
Egypt
Facility Name
Qena Fertility Center
City
Qena
ZIP/Postal Code
123456
Country
Egypt
Facility Name
IbnSina IVF Center
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate
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