Vitrification Versus Slow Cooling of Human Cleavage Stage Embryos
NCT ID: NCT00886431
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
146 participants
INTERVENTIONAL
2009-05-31
Brief Summary
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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.
Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vitrification
The embryos of patients allocated to this arm will be cryopreserved by vitrification.
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.
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)
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* participants of oocyte donation program
* participants of percutaneous spermatozoon aspiration (PESA) program
* couples with a finite source of spermatozoa
* absence of cryopreservable embryos
18 Years
35 Years
ALL
Yes
Sponsors
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Vrije Universiteit Brussel
OTHER
UMC Utrecht
OTHER
Responsible Party
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Bart CJM Fauser
Prof. dr. B Fauser
Principal Investigators
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Bart C Fauser, Prof.,MD,PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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Academic Hospital of Brussels
Brussels, , Belgium
University Medical Center of Utrecht
Utrecht, Utrecht, Netherlands
Countries
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References
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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. doi: 10.1002/mrd.20450.
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. doi: 10.1016/s0015-0282(99)00280-0.
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. doi: 10.1016/s1472-6483(10)60789-4.
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. doi: 10.1093/humrep/15.1.175.
Kasai M, Mukaida T. Cryopreservation of animal and human embryos by vitrification. Reprod Biomed Online. 2004 Aug;9(2):164-70. doi: 10.1016/s1472-6483(10)62125-6.
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. doi: 10.1016/s0015-0282(01)01968-9.
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. doi: 10.1016/s1472-6483(10)61135-2.
Salumets A, Suikkari AM, Makinen 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. doi: 10.1093/humrep/del151. 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. doi: 10.1093/humrep/del253. 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. doi: 10.1016/s1472-6483(10)61298-9.
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. doi: 10.1016/j.fertnstert.2004.12.051.
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. doi: 10.1016/s1472-6483(10)60869-3.
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. doi: 10.1016/j.fertnstert.2006.01.029. 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. doi: 10.1016/s0015-0282(01)01685-5.
Other Identifiers
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CCMO NL23499.000.08
Identifier Type: -
Identifier Source: secondary_id
METC 08/183
Identifier Type: -
Identifier Source: secondary_id
Vitrification study
Identifier Type: -
Identifier Source: org_study_id