Whether Using Sequential pH Would Improve Human Blastocyst Formation

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: pH Effect on blastocyst formation

• Registration Number: NCT03641014
• Lead Sponsor: Ibn Sina Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-21
• Study Start: 2018-08-28
• Primary Completion: 2019-05-30
• Study Completion: 2019-06-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-14
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1312

Inclusion Criteria

• ICSI cycles

Exclusion Criteria

• No exclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential pH culture (7.23 then 7.35)	pH Effect on blastocyst formation	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.

Primary Outcome Measures

Name	Time	Method
Ongoing Pregnancy rate	12 weeks	women with continued pregnancy at week 12 of gestation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Banon Assiut; 🇪🇬 Assiut, Egypt

Quena IVF Centre; 🇪🇬 Quena, Egypt

IbnSina IVF Center, IbnSina Hospital; 🇪🇬 Sohag, Egypt