Whether Using Sequential pH Would Improve Human Blastocyst Formation
Sequential pH Effect on Blastocyst Formation Rate
1 other identifier
interventional
1,312
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedStudy Start
First participant enrolled
August 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2019
CompletedJuly 16, 2019
July 1, 2019
9 months
August 10, 2018
July 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Ongoing Pregnancy rate
women with continued pregnancy at week 12 of gestation
12 weeks
Secondary Outcomes (4)
rate of usable blastocysts
6 days of culture
Blastocyst formation rate
6 days of culture
Clinical pregnancy rate
3 months
Implantation rate
7 weeks
Study Arms (2)
Sequential pH culture (7.23 then 7.35)
EXPERIMENTALA 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.
Continuously pH culture at 7.23
NO INTERVENTIONEmbryo culture from day 0 to 5 or 6 at 7.23
Interventions
to investigate which pH is suitable for each stage of embryo development
Eligibility Criteria
You may qualify if:
- ICSI cycles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ibn Sina Hospitallead
- Banoon IVF Centercollaborator
- Quena IVF Centrecollaborator
Study Sites (3)
Quena IVF Centre
Quena, Qena Governorate, 12346, Egypt
Banon Assiut
Asyut, Egypt
IbnSina IVF Center, IbnSina Hospital
Sohag, 12345, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- IVF Lab Director
Study Record Dates
First Submitted
August 10, 2018
First Posted
August 21, 2018
Study Start
August 28, 2018
Primary Completion
May 30, 2019
Study Completion
June 10, 2019
Last Updated
July 16, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share