Safety and Efficacy of Freezing and Thawing of Human Eggs in Assisted Reproductive Technology

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
ViaCell
ClinicalTrials.gov Identifier:
NCT00451009
First received: March 20, 2007
Last updated: May 28, 2014
Last verified: May 2014

March 20, 2007
May 28, 2014
March 2007
Not Provided
Live birth
Same as current
Complete list of historical versions of study NCT00451009 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Safety and Efficacy of Freezing and Thawing of Human Eggs in Assisted Reproductive Technology
Safety and Effectiveness of Freeze and Thaw Media Kits for the Manufacturing of Oocytes for Future Use in Assisted Reproductive Technology

The purpose of this study is to determine the effectiveness of the ViaCell's product media for freezing and thawing human eggs for future use in assisted reproductive technology.

ViaCell's product is an investigational product intended to broaden reproductive options for women through freezing and thawing of human eggs. The egg is a large cell with a high water content, historically making it difficult to freeze. It uses a choline chloride-based media designed to protect the cells from damage during the freezing process with the goal of making it possible to successfully store and thaw eggs for future use.

Following informed consent, female subjects will be screened according to the inclusion/exclusion criteria of the protocol and eligible subjects will undergo hormonal stimulation using standard IVF drugs.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
Device: Viacell's product Media Kits
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2009
Not Provided

Inclusion Criteria:

  • Women 21-35 years of age
  • Women with male factor infertility seeking IVF treatment
  • Negative history of female infertility
  • Non-smoking for at least 1 year

Exclusion Criteria:

  • Greater than one miscarriage
  • More than one previous failed IVF attempt
Female
21 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00451009
VRH-01
Yes
Not Provided
ViaCell
Not Provided
Not Provided
ViaCell
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP