Infertility Clinical Trial
Official title:
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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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