The Influence of Different Concentrations of Glucose in Culture Media on Fertilization and Embryo Quality

NCT ID: NCT00606073

Last Updated: 2008-02-01

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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The aim of this study is to examine whether incubation of human oocytes until pronuclear stage, in different culture media containing high and low concentrations of glucose affect fertilization differently, not only in standard IVF cycles, but also after intracytoplasmatic sperm injection.In addition, we wish to determine whether exposure of oocytes to different concentrations of glucose until pronuclear stage has further effect on embryo quality and development until the blastocyst stage.

Detailed Description

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Conditions

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Fertility

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

IVF Procedure-IVF Medium

Group Type ACTIVE_COMPARATOR

Universal IVF Medium + ISM1 Medium

Intervention Type OTHER

Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection. Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance. After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only. The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.

II

IVF Procedure - ISM1 Medium

Group Type ACTIVE_COMPARATOR

Universal IVF Medium + ISM1 Medium

Intervention Type OTHER

Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection. Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance. After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only. The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.

III

ICSI Procedure - IVF Medium

Group Type ACTIVE_COMPARATOR

Universal IVF Medium + ISM1 Medium

Intervention Type OTHER

Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection. Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance. After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only. The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.

IV

ICSI Procedure - ISM1 Medium

Group Type ACTIVE_COMPARATOR

Universal IVF Medium + ISM1 Medium

Intervention Type OTHER

Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection. Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance. After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only. The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.

Interventions

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Universal IVF Medium + ISM1 Medium

Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection. Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance. After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only. The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing IVF treatment in our clinic during study period

Exclusion Criteria

* Females older than 40 years
* Patients with less than 6 retrieved oocytes
* Male patients older than 50 years old
* Patients after testis biopsies
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hillel Yaffe Medical Center

Other Identifiers

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HYMC IRB#31/2007

Identifier Type: -

Identifier Source: org_study_id

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