The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 647
- 试验地点
- 1
- 主要终点
- clinical implantation rate per embryo transferred
研究概览
简要总结
The successful hatching process is a prerequisite for implantation. Freezing/thawing cycles can impair the hatching process by introducing changes in the composition of the zona pellucida. The purpose of this study is to test the hypothesis that the implantation rate per embryo and the clinical pregnancy rate per embryo transfer is higher after embryo transfer of frozen-thawed embryos with opened or thinned ZP after assisted hatching when compared to embryo transfer of frozen-thawed embryos without assisted hatching.
All patients starting a thawing cycle (with frozen embryos on d1-d2-d3-d5) can be included in this RTC study. Assisted hatching will be performed with a non-contact 1.48 diode laser system (MTG, Germany).
详细描述
In view of insufficient clinical evidence demonstrating the value of AH at the start of our study and in view of the need for higher implantation and LBRs in our ART programme within a series of reimbursed cycles, a prospective randomized controlled trial was performed to evaluate the effect of AH, by modified quarter laser-assisted zona thinning (mQLAZT), in our cryopreservation program. The primary aim was to test the hypothesis that the IR per embryo transferred is higher after transfer of frozen/vitrified-thawed/warmed embryos with thinned ZP after mQLAZT when compared with the transfer of frozen/vitrified-thawed/warmed embryos without mQLAZT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with frozen 2pn, embryos and blastocysts who want to start an embryo thawing cycle can be included in this study.
排除标准
- •Patients participating in the embryo reception program are excluded.
研究组 & 干预措施
control
control group without intervention
AH group
assisted hatching performed on the embryo
干预措施: assisted hatching (Procedure)
结局指标
主要结局
clinical implantation rate per embryo transferred
时间窗: at 6-8 weeks of pregnancy
次要结局
- pregnancy rate per transfer(at 14-16 days after ovulation or 17 days after the start of progesterone supplementation in a hormone replacement freeze-thaw cycle)
研究者
Sophie Debrock
PhD, clinical embryologist
KU Leuven