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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451009
Recruitment Status : Withdrawn
First Posted : March 22, 2007
Last Update Posted : May 29, 2014
Information provided by:

March 20, 2007
March 22, 2007
May 29, 2014
March 2007
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Live birth
Same as current
Complete list of historical versions of study NCT00451009 on Archive Site
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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.

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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Device: Viacell's product Media Kits
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2009
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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
Sexes Eligible for Study: Female
21 Years to 35 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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May 2014

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