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

ViaCell

Status: Withdrawn

Conditions: Infertility

Treatments: Device: Viacell's product Media Kits

Study type: Interventional

Funder types: Industry

Identifiers

NCT00451009

VRH-01

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 21 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)