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

May 28, 2014 updated by: ViaCell

Safety and Effectiveness of Freeze and Thaw Media Kits for the Manufacturing of Oocytes for Future Use in Assisted Reproductive Technology

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Ramon, California, United States, 94583
        • Reproductive Science Center
    • Florida
      • South Miami, Florida, United States, 33143
        • South Florida Institute for Reproductive Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics, Center for Advanced Reproductive Care
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Boston IVF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Live birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViaCell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRH-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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