Oocyte Cryopreservation by Slow Freezing and Vitrification

November 18, 2013 updated by: Reproductive Medicine Associates of New Jersey

Longitudinal Evaluation of Vitrification of Human Oocytes

This study seeks to evaluate whether the vitrification technique, as compared to the more traditional slow-cooling technique, leads to higher rates of successful thawing, fertilization, implantation and delivery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Cryopreservation (freezing) of human gametes (unfertilized egg) provides a great potential to preserve or extend fertility in the face of disease and social circumstances (cancer diagnosis, delaying childbirth, single women, etc.). There are two methods for storage of oocytes (unfertilized eggs): slow freezing or vitrification (uses higher concentrations of cryoprotectant and faster cooling rates). Slow freezing is the standard method and has been successful for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. The aim of this study is to examine the rate at which frozen eggs survive freezing and thawing, the rate at which the frozen/thawed eggs fertilize with sperm and the pregnancy outcomes of oocyte (egg) vitrification cycles to determine whether the outcomes are similar or better than standard oocyte (egg) cryopreservation (freezing) cycles.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 3

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 21 and 50 years, at the time of informed consent.
  • Subjects must agree to undergo intracytoplasmic sperm injection (ICSI)

Exclusion Criteria:

  • Presence of any medical condition that contraindicates ovarian stimulation, in vitro fertilization or pregnancy.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Slow Freezing
oocytes will be frozen by slow freeze/ rapid thaw
Procedure: slow freeze
Eggs will be placed in a cryo-protected solution and frozen slowly in a programable freezer
Other Names:
  • Cryopreservation
  • Traditional freezing
  • slow freezing
Experimental: Vitrification
oocytes will be frozen using rapid freezing/rapid thaw
Procedure: Vitrification
Eggs will be placed in a high concentration of cryo-protectant and frozen very quickly by plunging in liquid nitrogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocytes survival after thaw
Time Frame: 1 month
Whether each oocyte survives the thawing process
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization
Time Frame: 1 month
Whether each oocyte is successfully fertilized
1 month
Implantation
Time Frame: 1 month
Whether pregnancy occurs.
1 month

Collaborators and Investigators

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

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Study Director: Richard T Scott, MD, HCLD, RMA of NJ
  • Study Chair: Kathleen Ferry, BS, RMA of NJ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

July 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMA-2009-02

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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