Back to resultsSafety and Efficacy of Freezing and Thawing of Human Eggs in Assisted Reproductive Technology
Primary Purpose
Infertility
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Viacell's product Media Kits
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF, Male factor infertility, Cryopreservation, Cryoprotective agents, Egg Freezing
Eligibility 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
Sites / Locations
- Reproductive Science Center
- South Florida Institute for Reproductive Medicine
- University of Iowa Hospitals and Clinics, Center for Advanced Reproductive Care
- Boston IVF
Outcomes
Primary Outcome Measures
Live birth
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00451009
Brief Title
Safety and Efficacy of Freezing and Thawing of Human Eggs in Assisted Reproductive Technology
Official Title
Safety and Effectiveness of Freeze and Thaw Media Kits for the Manufacturing of Oocytes for Future Use in Assisted Reproductive Technology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
ViaCell
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, Male factor infertility, Cryopreservation, Cryoprotective agents, Egg Freezing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Viacell's product Media Kits
Primary Outcome Measure Information:
Title
Live birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Reproductive Science Center
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
South Florida Institute for Reproductive Medicine
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
University of Iowa Hospitals and Clinics, Center for Advanced Reproductive Care
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Boston IVF
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
12. IPD Sharing Statement
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Safety and Efficacy of Freezing and Thawing of Human Eggs in Assisted Reproductive Technology
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