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

Study Overview
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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.

Official Title
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The Influence of Different Concentrations of Glucose in Culture Media(i.e: ISM1 vs. IVF) on Fertilization and Embryo Quality

Conditions
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Fertility

Intervention / Treatment
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* Other: Universal IVF Medium + ISM1 Medium


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>IVF Procedure-IVF Medium | Other: Universal IVF Medium + ISM1 Medium<br>* 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.<br>|
| Active Comparator: II<br>IVF Procedure - ISM1 Medium | Other: Universal IVF Medium + ISM1 Medium<br>* 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.<br>|
| Active Comparator: III<br>ICSI Procedure - IVF Medium | Other: Universal IVF Medium + ISM1 Medium<br>* 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.<br>|
| Active Comparator: IV<br>ICSI Procedure - ISM1 Medium | Other: Universal IVF Medium + ISM1 Medium<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate and embryo quality |  | 6 days |