Vitrification Versus Slow Cooling of Human Cleavage Stage Embryos

November 26, 2014 updated by: Bart CJM Fauser, UMC Utrecht

A Double Blinded, Randomised Controlled Trial Comparing the Effectiveness of Vitrification to Slow Cooling in Cryopreserving Human Preimplantation Embryos

Human embryos can be preserved for later transfers by freezing. Traditionally the slow cooling method has been used. About 70% of the embryos remain fully intact after thawing. However, the remaining 30% of the embryos become (partially) damaged, and this freezing damage reduces their chance to implant. Recently an ultra rapid freezing method, called vitrification has been developed. During vitrification no damaging ice crystals are formed and the embryo freezes in a glass like state.

It appears that the freezing damage is reduced when embryos are vitrified. Observational studies in humans indicate that embryos are successfully preserved by vitrification, as indicated by promising pregnancy rates following thawing. However, the effectiveness of vitrification in relation to slow cooling with respect to pregnancy rates has so far not been evaluated by a randomised, controlled trial. The aim of this study is to investigate whether vitrification significantly improves embryo survival and ongoing pregnancy rates when compared to embryos frozen by slow cooling.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

time of allocation: following embryo selection

type of embryos: cleavage stage -, morula stage or early blastocyst stage embryo (day3 - day4 after oocyte collection)

cryoprotectants: sucrose, dimethylsulfoxide, ethyleneglycol

vitrification storage device: high security vitrification straws

Study Type

Interventional

Enrollment (Actual)

146

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

  • Belgium
      • Brussels, Belgium, 1090
        • Academic Hospital of Brussels
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center of Utrecht

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • female patient age 35 years or less
  • embryos are obtained by in vitro fertilization (IVF) or intra cytoplasmatic spermatozoon injection (ICSI)
  • single embryo transfer
  • 1rst IVF/ICSI treatment with an embryo transfer
  • availability of cryopreservable embryos

Exclusion Criteria:

  • female patient age is 36 years or older
  • participants of oocyte donation program
  • participants of percutaneous spermatozoon aspiration (PESA) program
  • couples with a finite source of spermatozoa
  • absence of cryopreservable embryos

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitrification
The embryos of patients allocated to this arm will be cryopreserved by vitrification.
Other: embryo vitrification
Ultra rapid cooling of embryos by immersion in liquid nitrogen. The formation of potentially damaging ice crystals is prevented by briefly incubating the embryos in high concentrations of a mix of cryoprotectants.
Other Names:
  • vitrification
  • high security vitrification straws
No Intervention: Slow cooling
The embryos of patients allocated to this arm will be cryopreserved by the slow cooling method, which is the standard method (=no intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percent change of the ongoing pregnancy rate per patient/couple who use their thawed embryos (following a fesh embryo transfer which did not result in an ongoing pregnancy) from baseline (slow cooling) to end point (vitrification).
Time Frame: ongoing pregnancy is established 10 weeks following the transfer of a frozen embryo
ongoing pregnancy is established 10 weeks following the transfer of a frozen embryo

Secondary Outcome Measures

Outcome Measure
Time Frame
post-thaw embryo survival rate
Time Frame: 1 hour after thawing
1 hour after thawing
ongoing pregnancy rate per patient using their thawed embryos (independent of whether they became pregnant following a fresh embryo transfer or not
Time Frame: 10 weeks following transfer of frozen thawed embryo
10 weeks following transfer of frozen thawed embryo
implantation rate per thawed embryo
Time Frame: 10 weeks after transfer of thawed embryo
10 weeks after transfer of thawed embryo
implantation rate per transferred thawed embryo
Time Frame: 10 weeks after transfer of thawed embryo
10 weeks after transfer of thawed embryo
cumulative implantation rate per cryopreservation
Time Frame: 10 weeks after thawed embryo transfer
10 weeks after thawed embryo transfer
ongoing pregnancy rate per frozen-thaw cycle
Time Frame: 10 weeks following thawed embryo transfer
10 weeks following thawed embryo transfer
average number of frozen-thawed cycles per patient
Time Frame: is variable
is variable
post thaw development (categorial) per thawed embryo
Time Frame: 24 hours following thawing
24 hours following thawing
average number of cryo-thaw cycles to ongoing pregnancy
Time Frame: variable, up to 3 years
variable, up to 3 years
average number of thawed embryos to ongoing implantation
Time Frame: variable, up to 3 years
variable, up to 3 years
Life birth rate
Time Frame: 9 month after pregnancy test
9 month after pregnancy test

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Collaborators

Vrije Universiteit Brussel

Investigators

  • Principal Investigator: Bart C Fauser, Prof.,MD,PhD, UMC Utrecht

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.

General Publications

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

May 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 22, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 26, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitrification study
  • CCMO NL23499.000.08
  • METC 08/183

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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