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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00451009
Recruitment Status : Withdrawn
First Posted : March 22, 2007
Last Update Posted : May 29, 2014
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Infertility Device: Viacell's product Media Kits

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : March 2007
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Live birth

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00451009     History of Changes
Other Study ID Numbers: VRH-01
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female