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CompletedNCT03641014Updated Jul 16, 2019

Whether Using Sequential pH Would Improve Human Blastocyst Formation

An interventional study of pH Effect on blastocyst formation in Infertility, sponsored by Ibn Sina Hospital. Completed at 3 sites in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Ibn Sina Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,312
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 1,312 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

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Lead sponsor

Ibn Sina Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • ICSI cycles

Exclusion criteria

Exclusion Criteria:

  • No exclusion
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
1,312 participants (actual)

Study arms

  • 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

  • No intervention
    Continuously pH culture at 7.23

    Embryo culture from day 0 to 5 or 6 at 7.23

Interventions

  • OtherpH Effect on blastocyst formation

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

06

What researchers measure

Primary outcomes

  1. Ongoing Pregnancy rate

    women with continued pregnancy at week 12 of gestation

    Time frame: 12 weeks

Secondary outcomes

  1. rate of usable blastocysts

    number of blastocysts suitable for transfer on day 5 or 6

    Time frame: 6 days of culture

  2. Blastocyst formation rate

    number of formed blastocyst per Fertilized oocyte

    Time frame: 6 days of culture

  3. Clinical pregnancy rate

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

    Time frame: 3 months

  4. Implantation rate

    number of sacs with a heartbeat

    Time frame: 7 weeks

07

Study locations

3 sites
  • Banon Assiut
    Assiut, Egypt
  • Quena IVF Centre
    Quena, 12346, Egypt
  • IbnSina IVF Center, IbnSina Hospital
    Sohag, 12345, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03641014
Lead sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Quena IVF Centre
Responsible party
Muhammad Fawzy (IVF Lab Director, Ibn Sina Hospital) — Principal investigator
First posted
Aug 21, 2018
Start date
Aug 28, 2018
Primary completion
May 30, 2019
Completion
Jun 10, 2019
Last update
Jul 16, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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