We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitrification Versus Slow Cooling of Human Cleavage Stage Embryos

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886431
First Posted: April 23, 2009
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vrije Universiteit Brussel
Information provided by (Responsible Party):
Bart CJM Fauser, UMC Utrecht
  Purpose

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.


Condition Intervention
Infertility Other: embryo vitrification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Double Blinded, Randomised Controlled Trial Comparing the Effectiveness of Vitrification to Slow Cooling in Cryopreserving Human Preimplantation Embryos

Further study details as provided by Bart CJM Fauser, UMC Utrecht:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • post-thaw embryo survival rate [ Time Frame: 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 ]
  • implantation rate per thawed embryo [ Time Frame: 10 weeks after transfer of thawed embryo ]
  • implantation rate per transferred thawed embryo [ Time Frame: 10 weeks after transfer of thawed embryo ]
  • cumulative implantation rate per cryopreservation [ Time Frame: 10 weeks after thawed embryo transfer ]
  • ongoing pregnancy rate per frozen-thaw cycle [ Time Frame: 10 weeks following thawed embryo transfer ]
  • average number of frozen-thawed cycles per patient [ Time Frame: is variable ]
  • post thaw development (categorial) per thawed embryo [ Time Frame: 24 hours following thawing ]
  • average number of cryo-thaw cycles to ongoing pregnancy [ Time Frame: variable, up to 3 years ]
  • average number of thawed embryos to ongoing implantation [ Time Frame: variable, up to 3 years ]
  • Life birth rate [ Time Frame: 9 month after pregnancy test ]

Enrollment: 146
Study Start Date: May 2009
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886431


Locations
Belgium
Academic Hospital of Brussels
Brussels, Belgium, 1090
Netherlands
University Medical Center of Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Vrije Universiteit Brussel
Investigators
Principal Investigator: Bart C Fauser, Prof.,MD,PhD UMC Utrecht
  More Information

Publications:

Responsible Party: Bart CJM Fauser, Prof. dr. B Fauser, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00886431     History of Changes
Other Study ID Numbers: Vitrification study
CCMO NL23499.000.08
METC 08/183
First Submitted: April 22, 2009
First Posted: April 23, 2009
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Bart CJM Fauser, UMC Utrecht:
IVF
embryo cryopreservation
vitrification
slow cooling
slow freezing
surplus embryos
Human Reproduction

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female