Vitrification Versus Slow Cooling of Human Cleavage Stage Embryos

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by UMC Utrecht.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Vrije Universiteit Brussel
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00886431
First received: April 22, 2009
Last updated: May 28, 2009
Last verified: May 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Double Blinded, Randomised Controlled Trial Comparing the Effectiveness of Vitrification to Slow Cooling in Cryopreserving Human Preimplantation Embryos

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • post-thaw embryo survival rate [ Time Frame: 1 hour after thawing ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • implantation rate per thawed embryo [ Time Frame: 10 weeks after transfer of thawed embryo ] [ Designated as safety issue: No ]
  • implantation rate per transferred thawed embryo [ Time Frame: 10 weeks after transfer of thawed embryo ] [ Designated as safety issue: No ]
  • cumulative implantation rate per cryopreservation [ Time Frame: 10 weeks after thawed embryo transfer ] [ Designated as safety issue: No ]
  • ongoing pregnancy rate per frozen-thaw cycle [ Time Frame: 10 weeks following thawed embryo transfer ] [ Designated as safety issue: No ]
  • average number of frozen-thawed cycles per patient [ Time Frame: is variable ] [ Designated as safety issue: No ]
  • post thaw development (categorial) per thawed embryo [ Time Frame: 24 hours following thawing ] [ Designated as safety issue: No ]
  • average number of cryo-thaw cycles to ongoing pregnancy [ Time Frame: variable, up to 3 years ] [ Designated as safety issue: No ]
  • average number of thawed embryos to ongoing implantation [ Time Frame: variable, up to 3 years ] [ Designated as safety issue: No ]
  • Life birth rate [ Time Frame: 9 month after pregnancy test ] [ Designated as safety issue: No ]

Estimated Enrollment: 626
Study Start Date: May 2009
Estimated 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
  • embryo 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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886431

Contacts
Contact: Dagmar R Gutknecht, PhD 0031887555555 d.r.gutknecht@umcutrecht.nl
Contact: Bart C Fauser, Prof,PhD,MD 0031887555555 b.c.fauser@umcutrecht.nl

Locations
Belgium
Academic Hospital of Brussels Recruiting
Brussels, Belgium, 1090
Contact: Etienne van den Abbeel, PhD    0032-2-4776690    etienne.vandenabbeel@az.vub.ac.be   
Contact: Paul Devroey, Prof, MD    003224776660    paul.devroey@az.vub.ac.be   
Principal Investigator: Etienne van den Abbeel, PhD         
Principal Investigator: Paul Devroey, Prof, MD         
Netherlands
University Medical Center of Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Dagmar R Gutknecht, PhD    0031-88-7555555    d.r.gutknecht@umcutrecht.nl   
Contact: Bart C Fauser, Prof, MD    0031887555555    b.c.fauser@umcutrecht.nl   
Principal Investigator: Bart C Fauser, Prof, MD         
Principal Investigator: Dagmar R Gutknecht, PhD         
Sponsors and Collaborators
UMC Utrecht
Vrije Universiteit Brussel
Investigators
Principal Investigator: Bart C Fauser, Prof.,MD,PhD UMC Utrecht
  More Information

Publications:

Responsible Party: Prof. Dr. B.C. Fauser, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00886431     History of Changes
Other Study ID Numbers: Vitrification study, CCMO NL23499.000.08, METC 08/183
Study First Received: April 22, 2009
Last Updated: May 28, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on October 20, 2014