A Double Blinded, Randomised Controlled Trial Comparing the Effectiveness of Vitrification to Slow Cooling in Cryopreserving Human Preimplantation Embryos
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 146
- 试验地点
- 4
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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).
时间窗: ongoing pregnancy is established 10 weeks following the transfer of a frozen embryo
次要结局
- post-thaw embryo survival rate(1 hour after thawing)
- implantation rate per thawed embryo(10 weeks after transfer of thawed embryo)
- cumulative implantation rate per cryopreservation(10 weeks after thawed embryo transfer)
- ongoing pregnancy rate per patient using their thawed embryos (independent of whether they became pregnant following a fresh embryo transfer or not(10 weeks following transfer of frozen thawed embryo)
- implantation rate per transferred thawed embryo(10 weeks after transfer of thawed embryo)
- ongoing pregnancy rate per frozen-thaw cycle(10 weeks following thawed embryo transfer)
- average number of frozen-thawed cycles per patient(is variable)
- average number of thawed embryos to ongoing implantation(variable, up to 3 years)
- post thaw development (categorial) per thawed embryo(24 hours following thawing)
- Life birth rate(9 month after pregnancy test)
- average number of cryo-thaw cycles to ongoing pregnancy(variable, up to 3 years)