Randomized Controlled Trial Comparing the Implantation Rate of Vitrified-warmed Blastocysts With and Without Artificial Shrinkage Before Vitrification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- implantation rate of the embryo in the first frozen transfer cycle
研究概览
简要总结
In our centre, the implantation rate of frozen blastocysts (cryopreserved using vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when compared to data from other observational studies. Retrospective studies have shown that artificial shrinkage of the blastocoelic cavity (also called collapse) and dehydration of the blastocyst just before vitrification can have a positive effect on the survival after warming. This collapse can be induced by using a laser. The study of Iwayama et al. 2010 has shown a similar survival rate but an increase in the implantation rate of collapsed blastocysts compared to non-collapsed blastocysts.
The aim of the study is to investigate the effect of artificial shrinkage by laser-induced collapse on the implantation potential of vitrified-warmed day 5 or day 6 blastocyst stage embryos in a prospective randomised controlled trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female age <39 years
- •at least 1 blastocyst available for cryopreservation
排除标准
- •sperm origin: testicular or epididymal sperm extraction
- •IVM (in-vitro maturation) cycles
- •PGD cycles (preimplantation genetic diagnosis)
研究组 & 干预措施
Collapse
This arm includes the patients where laser-induced collapse (=artificial shrinkage) of all blastocysts is performed before vitrification
干预措施: Collapse (Procedure)
control
This control arm includes the patients of which the blastocysts are vitrified without performing collapse
结局指标
主要结局
implantation rate of the embryo in the first frozen transfer cycle
时间窗: approximately 10 weeks after the first frozen embryo transfer
patients are enrolled in the study at oocyte retrieval. When patient is not pregnant after fresh embryo transfer, she comes back to use the frozen embryos at least one month after the initial inclusion. After the frozen embryo transfer, poshCG is measured 14 days after transfer. Approximately 10 weeks after transfer, implantation rate of the frozen embryos is assessed. This is the number of intra-uterine gestational sacs seen on ultrasound on the number of embryos transferred
次要结局
- survival rate of warmed blastocysts(0-30 minutes)
- implantation rate per warmed blastocyst(approximately 10 weeks after first frozen transfer)
研究者
Lisbet Van Landuyt
klinisch embryoloog
Centre for Reproductive Medicine, Belgium