Whether Using Sequential pH Would Improve Human Blastocyst Formation

Sequential pH Effect on Blastocyst Formation Rate

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: pH Effect on blastocyst formation

• Study Type: Interventional
• Enrollment (Actual): 1312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Banon Assiut
  • Quena, Egypt, 12346
    • Quena IVF Centre
  • Sohag, Egypt, 12345
    • IbnSina IVF Center, IbnSina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ICSI cycles

Exclusion Criteria:

• No exclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sequential pH culture (7.23 then 7.35); 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.	Other: pH Effect on blastocyst formation; to investigate which pH is suitable for each stage of embryo development
NO_INTERVENTION: Continuously pH culture at 7.23; Embryo culture from day 0 to 5 or 6 at 7.23

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ibn Sina Hospital
• Collaborators: Banoon IVF Center; Quena IVF Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 28, 2018
• Primary Completion (ACTUAL): May 30, 2019
• Study Completion (ACTUAL): June 10, 2019

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (ACTUAL): August 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: IbnSina-Sequential pH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No