Pregnancy Outcomes in Patients With Slow Developing Blastocysts: What is the Best Transfer Strategy? A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
This study evaluates which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade <4 by Gardner and Schoolcraft classification. All cycles will be cultured to day 6 and half the patients will undergo a fresh embryo transfer and the other half a frozen embryo transfer.
详细描述
A lack of established markers for predicting blastocyst development increases the risk of having no embryos or embryos not-fully expanded available for transfer. Slower but non-arrested embryos are frequently found to have progressed to blastocyst stage by the time of a day 6 transfer. In the absence of a receptive endometrium, embryo selection for fresh transfer may be futile, and cryopreservation could be a better option. The objective is to determine which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade <4 by Gardner and Schoolcraft classification. The investigators hypothesize that in bad prognosis patients with slow-developing blastocysts, vitrified-warmed embryo transfer will result in higher implantation, clinical and ongoing pregnancy and live birth rates than fresh embryo transfer.
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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All IVF cycles undergoing autologous fresh blastocyst embryo transfer
- •All IVF cycles in which the best available embryo for transfer is at expansion grade <4
排除标准
- •Ovum Donation cycles
- •Preimplantation genetic testing cycles
研究组 & 干预措施
Frozen Embryo Transfer
The best available embryo is at expansion grade <4 by Gardner classification 5 days after oocyte retrieval. Patient's embryos are cultured to day 6 and vitrified regardless of expansion grade. Arrested blastocysts are discarded. The single best available embryo is transferred under a cryo-synthetic cycle.
干预措施: Frozen Embryo Transfer (Procedure)
Fresh ET
The best available embryo is at expansion grade <4 by Gardner classification 5 days after oocyte retrieval. Patient's embryos are cultured to day 6 and transferred regardless of expansion grade. Arrested blastocysts are discarded.
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: 20 days after date of embryo transfer
Proportion of patients with the presence of a gestational sac seen by transvaginal ultrasonography 20 days after the embryo transfer
次要结局
- Biochemical Pregnancy Rate(9 days after date of embryo transfer)
- Live Birth Rate(24 weeks after the embryo transfer)
- Miscarriage Rate(14 weeks after the embryo transfer)
- Cryopreservation-thaw rate(1 day after the thawing procedure)
研究者
Jorge Rodriguez-Purata
Principal Investigator
Institut Universitari Dexeus