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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by ViaCell.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
ViaCell
ClinicalTrials.gov Identifier:
NCT00451009
First received: March 20, 2007
Last updated: April 28, 2008
Last verified: April 2008
History of Changes
  Purpose

The purpose of this study is to determine the effectiveness of the ViaCyte media for freezing and thawing human eggs for future use in assisted reproductive technology.


Condition Intervention
Infertility
 Device: Viacyte Media Kits

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of ViaCyte Freeze and Thaw Media Kits for the Manufactuing of Oocytes for Future Use in Assisted Reproductive Technology

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by ViaCell:

Primary Outcome Measures:
  • Live birth

Estimated Enrollment: 300
Study Start Date: March 2007
Estimated Study Completion Date: April 2009
Detailed Description:

ViaCyte 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. ViaCyte 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.

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451009

Locations
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
ViaCell
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00451009     History of Changes
Other Study ID Numbers: VRH-01
Study First Received: March 20, 2007
Last Updated: April 28, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Cryoprotective Agents
 Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013