Infertility
Conditions
Keywords
IVF, Male factor infertility, Cryopreservation, Cryoprotective agents, Egg Freezing
Brief summary
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.
Detailed description
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.
Interventions
DEVICEViacell's product Media Kits
Sponsors
ViaCell
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth | — |
Countries
United States
Outcome results
None listed