Whether Using Sequential pH Would Improve Human Blastocyst Formation

NCT ID: NCT03641014

Last Updated: 2019-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2019-06-10

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

pH Effect on blastocyst formation

Intervention Type OTHER

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

Continuously pH culture at 7.23

Embryo culture from day 0 to 5 or 6 at 7.23

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pH Effect on blastocyst formation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ICSI cycles

Exclusion Criteria

* No exclusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Banoon IVF Center

OTHER

Sponsor Role collaborator

Quena IVF Centre

UNKNOWN

Sponsor Role collaborator

Ibn Sina Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Muhammad Fawzy

IVF Lab Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Quena IVF Centre

Quena, Qena Governorate, Egypt

Site Status

Banon Assiut

Asyut, , Egypt

Site Status

IbnSina IVF Center, IbnSina Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IbnSina-Sequential pH

Identifier Type: -

Identifier Source: org_study_id

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