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OpenTrials
Completed

NCT Number: NCT03641014

Whether Using Sequential pH Would Improve Human Blastocyst Formation

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Quena IVF Centre, Quena, Qena Governorate, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICSI cycles

Exclusion criteria

  • No exclusion

Treatment and study plan

pH Effect on blastocyst formation

Other

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

Primary outcomes

  1. Ongoing Pregnancy rate

    Time frame: 12 weeks

    women with continued pregnancy at week 12 of gestation

Secondary outcomes

  1. rate of usable blastocysts

    Time frame: 6 days of culture

    number of blastocysts suitable for transfer on day 5 or 6

  2. Blastocyst formation rate

    Time frame: 6 days of culture

    number of formed blastocyst per Fertilized oocyte

  3. Clinical pregnancy rate

    Time frame: 3 months

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

  4. Implantation rate

    Time frame: 7 weeks

    number of sacs with a heartbeat

Sponsors and collaborators

Lead sponsor

Ibn Sina Hospital

Other Gov

Collaborators

  • Banoon IVF Center
  • Quena IVF Centre

Registry information

Official study title

Sequential pH Effect on Blastocyst Formation Rate

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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