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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

April 22, 2009
May 28, 2009
May 2009
May 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00886431 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Vitrification Versus Slow Cooling of Human Cleavage Stage Embryos
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Infertility
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
  • Experimental: Vitrification
    The embryos of patients allocated to this arm will be cryopreserved by vitrification.
    Intervention: Other: embryo vitrification
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
626
Not Provided
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact: Dagmar R Gutknecht, PhD 0031887555555 d.r.gutknecht@umcutrecht.nl
Contact: Bart C Fauser, Prof,PhD,MD 0031887555555 b.c.fauser@umcutrecht.nl
Belgium,   Netherlands
 
NCT00886431
Vitrification study, CCMO NL23499.000.08, METC 08/183
No
Prof. Dr. B.C. Fauser, UMC Utrecht
UMC Utrecht
Vrije Universiteit Brussel
Principal Investigator: Bart C Fauser, Prof.,MD,PhD UMC Utrecht
UMC Utrecht
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP