- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00886431
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.
Panoramica dello studio
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Vitrification
The embryos of patients allocated to this arm will be cryopreserved by 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.
Altri nomi:
|
Nessun intervento: 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)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
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).
Lasso di tempo: ongoing pregnancy is established 10 weeks following the transfer of a frozen embryo
|
ongoing pregnancy is established 10 weeks following the transfer of a frozen embryo
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
post-thaw embryo survival rate
Lasso di tempo: 1 hour after thawing
|
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
Lasso di tempo: 10 weeks following transfer of frozen thawed embryo
|
10 weeks following transfer of frozen thawed embryo
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implantation rate per thawed embryo
Lasso di tempo: 10 weeks after transfer of thawed embryo
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10 weeks after transfer of thawed embryo
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implantation rate per transferred thawed embryo
Lasso di tempo: 10 weeks after transfer of thawed embryo
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10 weeks after transfer of thawed embryo
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cumulative implantation rate per cryopreservation
Lasso di tempo: 10 weeks after thawed embryo transfer
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10 weeks after thawed embryo transfer
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ongoing pregnancy rate per frozen-thaw cycle
Lasso di tempo: 10 weeks following thawed embryo transfer
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10 weeks following thawed embryo transfer
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average number of frozen-thawed cycles per patient
Lasso di tempo: is variable
|
is variable
|
post thaw development (categorial) per thawed embryo
Lasso di tempo: 24 hours following thawing
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24 hours following thawing
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average number of cryo-thaw cycles to ongoing pregnancy
Lasso di tempo: variable, up to 3 years
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variable, up to 3 years
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average number of thawed embryos to ongoing implantation
Lasso di tempo: variable, up to 3 years
|
variable, up to 3 years
|
Life birth rate
Lasso di tempo: 9 month after pregnancy test
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9 month after pregnancy test
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Bart C Fauser, Prof.,MD,PhD, Umc Utrecht
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Vitrification study
- CCMO NL23499.000.08
- METC 08/183
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