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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00451009
• Other study ID #: VRH-01
• Status: Withdrawn
• Phase: N/A
• First received: March 20, 2007
• Last updated: May 28, 2014
• Start date: March 2007
• Est. completion date: April 2009

Study information

• Verified date: May 2014
• Source: ViaCell
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Viacell's product Media Kits

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics, Center for Advanced Reproductive Care	Iowa City	Iowa
United States	Reproductive Science Center	San Ramon	California
United States	South Florida Institute for Reproductive Medicine	South Miami	Florida
United States	Boston IVF	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ViaCell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth