A Randomized Trial Comparing the Live Birth Rate of Immediate Versus Delayed Frozen Embryo Transfer (FET) Replacing a Single Blastocyst in the First FET of the First Stimulated IVF Cycle Following a Freeze-all Strategy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 828
- 试验地点
- 1
- 主要终点
- live birth
研究概览
简要总结
This randomized trial we aim to compare the live birth rate of immediate versus delayed FET replacing a single blastocyst in the first FET of the first stimulated IVF cycle following. The hypothesis is that the live birth rate of the immediate FET is higher than the delayed FET replacing a single blastocyst in the first FET of the first stimulated IVF cycle following a freeze-all strategy. Women will undergo IVF/ICSI in the centre as clinically indicated. Standard ovarian stimulation with gonadotrophins in a Gonadotrophin releasing hormone (GnRH) antagonist protocol will be employed. Hormone replacement treatment (HRT) will be used in subsequent FET cycles. On Day 3 of the menstrual cycle, we will measure the anxiety levels using the Chinese State-Trait Anxiety Inventory and serum E2, cortisol levels will be checked on the same day.
Recruited women having the first FET cycle following a freeze all strategy will be randomly assigned on the day of blastocyst(s) freezing according to a computer-generated randomization list into one of the following two groups.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-40 years at the time of IVF/ICSI
- •Women undergoing their first FET of the first IVF cycle following a freeze-all strategy
- •Undergoing IVF with GnRH antagonist
- •At least one frozen blastocyst
排除标准
- •Severe ovarian hyperstimulation syndrome during the first IVF/ICSI cycle
- •Preimplantation genetic testing
- •Use of donor oocytes
- •Presence of untreated hydrosalpinx or endometrial polyp on scanning during ovarian stimulation
研究组 & 干预措施
Immediate FET group
FET will be performed in the first menstrual cycle following the stimulated IVF cycle
干预措施: Immediate FET (Procedure)
Delayed FET group
FET will be performed in the second menstrual cycle following the stimulated IVF cycle
干预措施: Delayed FET (Procedure)
结局指标
主要结局
live birth
时间窗: 1 year after FET
deliveries ≥22 weeks gestation with heartbeat and breath
次要结局
- implantation rate(6 weeks' gestation)
- ectopic pregnancy(ectopic pregnancy during 12 weeks gestation)
- ongoing pregnancy(12 weeks' gestation)
- positive hCG(2 weeks after FET)
- clinical pregnancy(6 weeks' gestation)
- miscarriage(1 year after FET)
- multiple pregnancy(multiple pregnancy beyond gestation 12 weeks)
- birthweight of newborns(1 year after FET)