Whether Using Sequential pH Would Improve Human Blastocyst Formation

Infertility Clinical Trial

Official title:

Sequential pH Effect on Blastocyst Formation Rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641014
• Other study ID #: IbnSina-Sequential pH
• Status: Completed
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: June 10, 2019

Study information

• Verified date: July 2019
• Source: Ibn Sina Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1312
• Est. completion date: June 10, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• ICSI cycles

Exclusion Criteria:

• No exclusion

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• pH Effect on blastocyst formation
to investigate which pH is suitable for each stage of embryo development

Locations

Country	Name	City	State
Egypt	Banon Assiut	Assiut
Egypt	Quena IVF Centre	Quena
Egypt	IbnSina IVF Center, IbnSina Hospital	Sohag

Sponsors (3)

Lead Sponsor	Collaborator
Ibn Sina Hospital	Banoon IVF Center, Quena IVF Centre

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Pregnancy rate	women with continued pregnancy at week 12 of gestation	12 weeks
Secondary	rate of usable blastocysts	number of blastocysts suitable for transfer on day 5 or 6	6 days of culture
Secondary	Blastocyst formation rate	number of formed blastocyst per Fertilized oocyte	6 days of culture
Secondary	Clinical pregnancy rate	number of women with ultrasound detection of sacs with heartbeat per stimulated cycle	3 months
Secondary	Implantation rate	number of sacs with a heartbeat	7 weeks