A New System for Preventing Thermal Stress During Embryo Transfer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- Ongoing Pregnancy rate
研究概览
简要总结
The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability.
The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process.
With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.
排除标准
- •Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.
研究组 & 干预措施
Conventional transfer
This arm is the control group (conventional embryo transfer protocol) where there is no intervention.
Thermostable device transfer
This arm is the study group: embryo transfer protocol using a new thermostable device.
干预措施: Thermostable device (Device)
结局指标
主要结局
Ongoing Pregnancy rate
时间窗: Ongoing pregnancy until 28th week of gestation
Achieving an ongoing pregnancy after embryo transfer
次要结局
- Miscarriage rate(Loss of pregnancy up to 12 weeks of gestation)
- Implantation rate(Embryo implantation after 6-7 weeks of gestation)
研究者
Rafael Bernabeu Pérez
Gynecologist; M D; Ph D
Instituto Bernabeu