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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00606073
First received: January 21, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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 Intervention
Fertility
Other: Universal IVF Medium + ISM1 Medium

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Fertilization rate and embryo quality [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Medeia Michaeli, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00606073     History of Changes
Other Study ID Numbers: HYMC IRB#31/2007
Study First Received: January 21, 2008
Last Updated: January 21, 2008
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on July 20, 2014