Vitrification Versus Slow Cooling of Human Cleavage Stage Embryos
Information source: UMC Utrecht
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: embryo vitrification (Other)
Phase: N/A
Status: Terminated
Sponsored by: UMC Utrecht Official(s) and/or principal investigator(s): Bart C Fauser, Prof.,MD,PhD, Principal Investigator, Affiliation: UMC Utrecht
Summary
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.
Clinical Details
Official title: A Double Blinded, Randomised Controlled Trial Comparing the Effectiveness of Vitrification to Slow Cooling in Cryopreserving Human Preimplantation Embryos
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: 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).
Secondary outcome: post-thaw embryo survival rateongoing pregnancy rate per patient using their thawed embryos (independent of whether they became pregnant following a fresh embryo transfer or not implantation rate per thawed embryo implantation rate per transferred thawed embryo cumulative implantation rate per cryopreservation ongoing pregnancy rate per frozen-thaw cycle average number of frozen-thawed cycles per patient post thaw development (categorial) per thawed embryo average number of cryo-thaw cycles to ongoing pregnancy average number of thawed embryos to ongoing implantation Life birth rate
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
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
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
Locations and Contacts
Academic Hospital of Brussels, Brussels 1090, Belgium
University Medical Center of Utrecht, Utrecht 3584 CX, Netherlands
Additional Information
Related publications: Boonkusol D, Gal AB, Bodo S, Gorhony B, Kitiyanant Y, Dinnyes A. Gene expression profiles and in vitro development following vitrification of pronuclear and 8-cell stage mouse embryos. Mol Reprod Dev. 2006 Jun;73(6):700-8. Burns WN, Gaudet TW, Martin MB, Leal YR, Schoen H, Eddy CA, Schenken RS. Survival of cryopreservation and thawing with all blastomeres intact identifies multicell embryos with superior frozen embryo transfer outcome. Fertil Steril. 1999 Sep;72(3):527-32. Desai N, Blackmon H, Szeptycki J, Goldfarb J. Cryoloop vitrification of human day 3 cleavage-stage embryos: post-vitrification development, pregnancy outcomes and live births. Reprod Biomed Online. 2007 Feb;14(2):208-13. Edgar DH, Bourne H, Speirs AL, McBain JC. A quantitative analysis of the impact of cryopreservation on the implantation potential of human early cleavage stage embryos. Hum Reprod. 2000 Jan;15(1):175-9. Kasai M, Mukaida T. Cryopreservation of animal and human embryos by vitrification. Reprod Biomed Online. 2004 Aug;9(2):164-70. Review. Mukaida T, Nakamura S, Tomiyama T, Wada S, Kasai M, Takahashi K. Successful birth after transfer of vitrified human blastocysts with use of a cryoloop containerless technique. Fertil Steril. 2001 Sep;76(3):618-20. Rama Raju GA, Haranath GB, Krishna KM, Prakash GJ, Madan K. Vitrification of human 8-cell embryos, a modified protocol for better pregnancy rates. Reprod Biomed Online. 2005 Oct;11(4):434-7. Salumets A, Suikkari AM, Mäkinen S, Karro H, Roos A, Tuuri T. Frozen embryo transfers: implications of clinical and embryological factors on the pregnancy outcome. Hum Reprod. 2006 Sep;21(9):2368-74. Epub 2006 May 9. Sheehan CB, Lane M, Gardner DK. The CryoLoop facilitates re-vitrification of embryos at four successive stages of development without impairing embryo growth. Hum Reprod. 2006 Nov;21(11):2978-84. Epub 2006 Sep 1. Stehlik E, Stehlik J, Katayama KP, Kuwayama M, Jambor V, Brohammer R, Kato O. Vitrification demonstrates significant improvement versus slow freezing of human blastocysts. Reprod Biomed Online. 2005 Jul;11(1):53-7. Takahashi K, Mukaida T, Goto T, Oka C. Perinatal outcome of blastocyst transfer with vitrification using cryoloop: a 4-year follow-up study. Fertil Steril. 2005 Jul;84(1):88-92. Al-Hasani S, Ozmen B, Koutlaki N, Schoepper B, Diedrich K, Schultze-Mosgau A. Three years of routine vitrification of human zygotes: is it still fair to advocate slow-rate freezing? Reprod Biomed Online. 2007 Mar;14(3):288-93. Liebermann J, Tucker MJ. Comparison of vitrification and conventional cryopreservation of day 5 and day 6 blastocysts during clinical application. Fertil Steril. 2006 Jul;86(1):20-6. Epub 2006 Jun 8. Yokota Y, Sato S, Yokota M, Yokota H, Araki Y. Birth of a healthy baby following vitrification of human blastocysts. Fertil Steril. 2001 May;75(5):1027-9.
Starting date: May 2009
Last updated: November 26, 2014
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