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

This study has been withdrawn prior to enrollment.
Information provided by:
ViaCell Identifier:
First received: March 20, 2007
Last updated: May 28, 2014
Last verified: May 2014
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.

Condition Intervention
Infertility Device: Viacell's product Media Kits

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Freeze and Thaw Media Kits for the Manufacturing of Oocytes for Future Use in Assisted Reproductive Technology

Resource links provided by NLM:

Further study details as provided by ViaCell:

Primary Outcome Measures:
  • Live birth

Enrollment: 0
Study Start Date: March 2007
Estimated Study Completion Date: April 2009
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.


Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00451009

United States, California
Reproductive Science Center
San Ramon, California, United States, 94583
United States, Florida
South Florida Institute for Reproductive Medicine
South Miami, Florida, United States, 33143
United States, Iowa
University of Iowa Hospitals and Clinics, Center for Advanced Reproductive Care
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Boston IVF
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
  More Information Identifier: NCT00451009     History of Changes
Other Study ID Numbers: VRH-01
Study First Received: March 20, 2007
Last Updated: May 28, 2014

Keywords provided by ViaCell:
Male factor infertility
Cryoprotective agents
Egg Freezing

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on September 21, 2017