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Whether Using Sequential pH Would Improve Human Blastocyst Formation

Sponsor
Ibn Sina Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03641014
Collaborator
Banoon IVF Center (Other), Quena IVF Centre (Other)
1,312
Enrollment
3
Locations
2
Arms
9.4
Actual Duration (Months)
437.3
Patients Per Site
46.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: pH Effect on blastocyst formation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1312 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Sequential pH Effect on Blastocyst Formation Rate
Actual Study Start Date :
Aug 28, 2018
Actual Primary Completion Date :
May 30, 2019
Actual Study Completion Date :
Jun 10, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Ongoing Pregnancy rate [12 weeks]

    women with continued pregnancy at week 12 of gestation

Secondary Outcome Measures

  1. rate of usable blastocysts [6 days of culture]

    number of blastocysts suitable for transfer on day 5 or 6

  2. Blastocyst formation rate [6 days of culture]

    number of formed blastocyst per Fertilized oocyte

  3. Clinical pregnancy rate [3 months]

    number of women with ultrasound detection of sacs with heartbeat per stimulated cycle

  4. Implantation rate [7 weeks]

    number of sacs with a heartbeat

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ICSI cycles
Exclusion Criteria:
  • No exclusion

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banon Assiut Assiut Egypt
2 Quena IVF Centre Quena Egypt 12346
3 IbnSina IVF Center, IbnSina Hospital Sohag Egypt 12345

Sponsors and Collaborators

  • Ibn Sina Hospital
  • Banoon IVF Center
  • Quena IVF Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier:
NCT03641014
Other Study ID Numbers:
  • IbnSina-Sequential pH
First Posted:
Aug 21, 2018
Last Update Posted:
Jul 16, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of Jul 16, 2019