The Influence of Different Concentrations of Glucose in Culture Media on Fertilization and Embryo Quality - Full Text View

Sponsored by:	Hillel Yaffe Medical Center
Information provided by:	Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT00606073

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:	Treatment, Open Label, Parallel Assignment
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
I: Active Comparator 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.
II: Active Comparator 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.
III: Active Comparator 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.
IV: Active Comparator 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

No Contacts or Locations Provided

More Information

No publications provided

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

Study placed in the following topic categories:

Infertility

ClinicalTrials.gov processed this record on September 03, 2009