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

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ClinicalTrials.gov Identifier: NCT00606073
Recruitment Status : Unknown
Verified January 2008 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 1, 2008
Last Update Posted : February 1, 2008
Sponsor:
Information provided by:
Hillel Yaffe Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fertility Other: Universal IVF Medium + ISM1 Medium Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Influence of Different Concentrations of Glucose in Culture Media(i.e: ISM1 vs. IVF) on Fertilization and Embryo Quality
Study Start Date : February 2008
Estimated Primary Completion Date : August 2009
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: I
IVF Procedure-IVF Medium
 Other: 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.
Active Comparator: II
IVF Procedure - ISM1 Medium
 Other: 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.
Active Comparator: III
ICSI Procedure - IVF Medium
 Other: 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.
Active Comparator: IV
ICSI Procedure - ISM1 Medium
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Fertilization rate and embryo quality [ Time Frame: 6 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Dr. Medeia Michaeli, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00606073    
Other Study ID Numbers: HYMC IRB#31/2007
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: February 1, 2008
Last Verified: January 2008