- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Description détaillée
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
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
Autres noms:
|
Aucune 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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
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).
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
post-thaw embryo survival rate
Délai: 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
Délai: 10 weeks following transfer of frozen thawed embryo
|
10 weeks following transfer of frozen thawed embryo
|
implantation rate per thawed embryo
Délai: 10 weeks after transfer of thawed embryo
|
10 weeks after transfer of thawed embryo
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implantation rate per transferred thawed embryo
Délai: 10 weeks after transfer of thawed embryo
|
10 weeks after transfer of thawed embryo
|
cumulative implantation rate per cryopreservation
Délai: 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
Délai: 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
Délai: is variable
|
is variable
|
post thaw development (categorial) per thawed embryo
Délai: 24 hours following thawing
|
24 hours following thawing
|
average number of cryo-thaw cycles to ongoing pregnancy
Délai: variable, up to 3 years
|
variable, up to 3 years
|
average number of thawed embryos to ongoing implantation
Délai: variable, up to 3 years
|
variable, up to 3 years
|
Life birth rate
Délai: 9 month after pregnancy test
|
9 month after pregnancy test
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Bart C Fauser, Prof.,MD,PhD, UMC Utrecht
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Vitrification study
- CCMO NL23499.000.08
- METC 08/183
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