Back to resultsWhether Using Sequential pH Would Improve Human Blastocyst Formation
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pH Effect on blastocyst formation
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- ICSI cycles
Exclusion Criteria:
- No exclusion
Sites / Locations
- Banon Assiut
- Quena IVF Centre
- IbnSina IVF Center, IbnSina Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sequential pH culture (7.23 then 7.35)
Continuously pH culture at 7.23
Arm Description
A split embryo at day 3 to continue culture at a pHe of 7.23±0.02 or to be cultured at a pH of 7.35±0.02 and monitor the effect on blastocyst development.
Embryo culture from day 0 to 5 or 6 at 7.23
Outcomes
Primary Outcome Measures
Ongoing Pregnancy rate
women with continued pregnancy at week 12 of gestation
Secondary Outcome Measures
rate of usable blastocysts
number of blastocysts suitable for transfer on day 5 or 6
Blastocyst formation rate
number of formed blastocyst per Fertilized oocyte
Clinical pregnancy rate
number of women with ultrasound detection of sacs with heartbeat per stimulated cycle
Implantation rate
number of sacs with a heartbeat
Full Information
NCT ID
NCT03641014
First Posted
August 10, 2018
Last Updated
July 14, 2019
Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Quena IVF Centre
1. Study Identification
Unique Protocol Identification Number
NCT03641014
Brief Title
Whether Using Sequential pH Would Improve Human Blastocyst Formation
Official Title
Sequential pH Effect on Blastocyst Formation Rate
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Quena IVF Centre
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
Any drift in extracellular pH (pHe) from the intercellular pH (pHi) could alter the mechanism regulating transporters and exchangers through the plasma membrane. This could lead to difficulty in restoring the physiological level of pHi. The critical stages that lack robust mechanism of regulating the pHi are the denuded oocyte, early stage of fertilization or a thawed embryo. This, in turn, could lead to a significant effect of the perturbations on embryo development. Convincing evidence regarding the optimal pHe for culturing human embryo is, so far, scanty and mostly anecdotal. The embryo has been reported to have a compensatory mechanism to grow at pHe between 7.0-7.4. Others have recommended that embryo need a sequential pH to viably grow suggesting that the post-genomic activation stage needs a slightly alkaline range of pH. However, whether this holds true remains to be examined.
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequential pH culture (7.23 then 7.35)
Arm Type
Experimental
Arm Description
A split embryo at day 3 to continue culture at a pHe of 7.23±0.02 or to be cultured at a pH of 7.35±0.02 and monitor the effect on blastocyst development.
Arm Title
Continuously pH culture at 7.23
Arm Type
No Intervention
Arm Description
Embryo culture from day 0 to 5 or 6 at 7.23
Intervention Type
Other
Intervention Name(s)
pH Effect on blastocyst formation
Intervention Description
to investigate which pH is suitable for each stage of embryo development
Primary Outcome Measure Information:
Title
Ongoing Pregnancy rate
Description
women with continued pregnancy at week 12 of gestation
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
rate of usable blastocysts
Description
number of blastocysts suitable for transfer on day 5 or 6
Time Frame
6 days of culture
Title
Blastocyst formation rate
Description
number of formed blastocyst per Fertilized oocyte
Time Frame
6 days of culture
Title
Clinical pregnancy rate
Description
number of women with ultrasound detection of sacs with heartbeat per stimulated cycle
Time Frame
3 months
Title
Implantation rate
Description
number of sacs with a heartbeat
Time Frame
7 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 cycles
Exclusion Criteria:
No exclusion
Facility Information:
Facility Name
Banon Assiut
City
Assiut
Country
Egypt
Facility Name
Quena IVF Centre
City
Quena
ZIP/Postal Code
12346
Country
Egypt
Facility Name
IbnSina IVF Center, IbnSina Hospital
City
Sohag
ZIP/Postal Code
12345
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Whether Using Sequential pH Would Improve Human Blastocyst Formation
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