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

Tracking Information
First Received Date ^ICMJE	March 20, 2007
Last Updated Date	April 28, 2008
Start Date ^ICMJE	March 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: March 20, 2007)	Live birth
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00451009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Freezing and Thawing of Human Eggs in Assisted Reproductive Technology
Official Title ^ICMJE	Safety and Effectiveness of ViaCyte Freeze and Thaw Media Kits for the Manufactuing of Oocytes for Future Use in Assisted Reproductive Technology
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Infertility
Intervention ^ICMJE	Device: Viacyte Media Kits
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	300
Estimated Completion Date	April 2009
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	21 Years to 35 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00451009
Other Study ID Numbers ^ICMJE	VRH-01
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	ViaCell
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ViaCell
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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