Whether Using Sequential pH Would Improve Human Blastocyst Formation

Sequential pH Effect on Blastocyst Formation Rate

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03641014

Enrollment

1312

Registered

2018-08-21

Start date

2018-08-28

Completion date

2019-06-10

Last updated

2019-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

OTHERpH Effect on blastocyst formation

to investigate which pH is suitable for each stage of embryo development

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* ICSI cycles

Exclusion criteria

* No exclusion

Design outcomes

Primary

Measure	Time frame	Description
Ongoing Pregnancy rate	12 weeks	women with continued pregnancy at week 12 of gestation

Secondary

Measure	Time frame	Description
rate of usable blastocysts	6 days of culture	number of blastocysts suitable for transfer on day 5 or 6
Blastocyst formation rate	6 days of culture	number of formed blastocyst per Fertilized oocyte
Clinical pregnancy rate	3 months	number of women with ultrasound detection of sacs with heartbeat per stimulated cycle
Implantation rate	7 weeks	number of sacs with a heartbeat

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026