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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
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.
Academic Hospital of Brussels
Brussels, Belgium
University Medical Center of Utrecht
Utrecht, Utrecht, Netherlands
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
post-thaw embryo survival rate
Time frame: 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
Time frame: 10 weeks following transfer of frozen thawed embryo
implantation rate per thawed embryo
Time frame: 10 weeks after transfer of thawed embryo
implantation rate per transferred thawed embryo
Time frame: 10 weeks after transfer of thawed embryo
cumulative implantation rate per cryopreservation
Time frame: 10 weeks after thawed embryo transfer
ongoing pregnancy rate per frozen-thaw cycle
Time frame: 10 weeks following thawed embryo transfer
average number of frozen-thawed cycles per patient
Time frame: is variable
post thaw development (categorial) per thawed embryo
Time frame: 24 hours following thawing
average number of cryo-thaw cycles to ongoing pregnancy
Time frame: variable, up to 3 years
average number of thawed embryos to ongoing implantation
Time frame: variable, up to 3 years
Life birth rate
Time frame: 9 month after pregnancy test
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