NCT00606073

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Last Updated

February 1, 2008

Status Verified

January 1, 2008

Enrollment Period

1.5 years

First QC Date

January 21, 2008

Last Update Submit

January 21, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fertilization rate and embryo quality

    6 days

Study Arms (4)

I

ACTIVE COMPARATOR

IVF Procedure-IVF Medium

Other: Universal IVF Medium + ISM1 Medium

II

ACTIVE COMPARATOR

IVF Procedure - ISM1 Medium

Other: Universal IVF Medium + ISM1 Medium

III

ACTIVE COMPARATOR

ICSI Procedure - IVF Medium

Other: Universal IVF Medium + ISM1 Medium

IV

ACTIVE COMPARATOR

ICSI Procedure - ISM1 Medium

Other: Universal IVF Medium + ISM1 Medium

Interventions

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.

IIIIIIIV

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing IVF treatment in our clinic during study period

You may not qualify if:

  • Females older than 40 years
  • Patients with less than 6 retrieved oocytes
  • Male patients older than 50 years old
  • Patients after testis biopsies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 1, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Last Updated

February 1, 2008

Record last verified: 2008-01