The Live Birth Rate Between Single and Multi-step Warming Protocol Applied in Blastocyst Vitrification: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 816
- 试验地点
- 2
- 主要终点
- Live birth rate
研究概览
简要总结
The multi-step thawing protocol with a reduction of non-permeable cryoprotectant concentrations to reduce osmotic shock caused by the rapid influx of water. Recent studies have shown that a simplified warming protocol by only a thawing solution gave a comparable survival rate but increased pregnancy rate, reduced patients' waiting time, and decreased the workload of embryologists.
详细描述
Nowadays, vitrification is the gold standard method in freezing human embryos, using different commercial brands of ready-to-use kits. Removing cytotoxic cryoprotectants and rehydration to prevent osmotic shock has been a fundamental principle in cryobiology. This minimized damage during the vitrification/thawing (V/T) process. However, the entire process is time-consuming and labor-intensive in the IVF laboratory. Especially, some laboratories have difficulty ordering the same brand of medium for V/T kits. Because of the long period of cryopreserved embryos, it may be that embryos were vitrified and warmed with different kits with a potentially different kind and concentrations of cryoprotective agents. Recently, the combinations of the two different V/T commercial kits have shown comparable survival, blastulation, and implantation rates in both own and donor oocyte cycles.
Additionally, there remains an opportunity and a necessity to continue improving the warming protocol. The key factors for thawing require a fast warming rate, a gradually decreasing concentration of intracellular cryoprotectant, and embryologist skills to secure the survival rate.
Based on previous work, one option would be shortening the time necessary to rehydrate. A study by Seki and Mazur has shown that embryo survival is almost entirely dependent on the warming rate rather than the extracellular cryoprotectant concentration used. A recent study by Liebermann showed that simplifying warming procedures in one step by using 1M sucrose only is possible with an encouragingly higher ongoing pregnancy rate and comparable clinical outcomes when compared to the same conventional multi-step warming protocol, showing a significantly lower miscarriage rate (4.0% vs. 7.6%). These results lead to a faster, safer, and more cost-effective procedure.
This study aims to investigate the effectiveness and safety of a new combination of V/W solutions-single and multi-step thawing protocol- on live birth rate (LBR), as well as embryo transfer, obstetric, and neonatal outcomes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged from 18
- •Undergoing no more than 3 previous IVF/ICSI cycles
- •Had at least a single good-quality blastocyst frozen.
- •Endometrium preparation using artificial cycle
- •Agree to single blastocyst transfer
- •Not participating in any interventional studies at the same time
排除标准
- •Embryos from cycles after in-vitro maturation, pre-implantation genetic testing (PGT)
- •Having contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)
- •Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx or endometrial polyp)
结局指标
主要结局
Live birth rate
时间窗: At 22 weeks of gestation
Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown
次要结局
- Survival rate(At least 2 hours after thawing.)
- Cancellation rate(Any day during endometrium preparation days before embryo transfer.)
- Positive pregnancy test(At 2 weeks after embryo placement)
- Implantation rate(At 3 weeks after embryo placement)
- Preterm delivery(At 22, 28, 32 weeks and 37 weeks of gestation)
- Clinical pregnancy(At 5 weeks after embryo placement)
- Miscarriage(before 22 completed weeks of gestational age)
- Low birth weight(At the time of delivery)
- High birth weight(At the time of delivery)
- Multiple delivery(At 22 weeks' gestation)
- Ectopic pregnancy(At 7 weeks of gestation)
- Ongoing pregnancy(At 10 weeks after embryo placement)
- Major congenital abnormalities(At birth)
- Birth weight(At the time of delivery)
- Admission to NICU(At birth)
- Multiple pregnancy(At 6 to 8 weeks' gestation)
- Very low birth weight(At the time of delivery)
- Still birth(At 20 weeks' gestation)
- Neonatal mortality(within 28 days of birth)
- Direct costs to live birth(At the time of delivery)
- Preterm delivery(At 22, 28, 32 weeks and 37 weeks of gestation)
- Survival rate(At least 2 hours after thawing.)
- Cancellation rate(Any day during endometrium preparation days before embryo transfer.)
- Positive pregnancy test(At 2 weeks after embryo placement)
- Implantation rate(At 3 weeks after embryo placement)
- Clinical pregnancy(At 5 weeks after embryo placement)
- Ectopic pregnancy(At 7 weeks of gestation)
- Ongoing pregnancy(At 10 weeks after embryo placement)
- Miscarriage(before 22 completed weeks of gestational age)
- Major congenital abnormalities(At birth)
- Birth weight(At the time of delivery)
- Low birth weight(At the time of delivery)
- Very low birth weight(At the time of delivery)
- High birth weight(At the time of delivery)
- Admission to NICU(At birth)
- Multiple pregnancy(At 6 to 8 weeks' gestation)
- Multiple delivery(At 22 weeks' gestation)
- Still birth(At 20 weeks' gestation)
- Neonatal mortality(within 28 days of birth)
- Direct costs to live birth(At the time of delivery)