Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders, a Multicenter Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 845
- 试验地点
- 1
- 主要终点
- Live birth after the first embryo transfer
研究概览
简要总结
This is a multicenter, randomised controlled trial. The investigators plan to randomise 836 participants to the immediate FET or the postponed FET from the day of oocyte retrieval to the last day of that menstrual cycle in a 1:1 rate. Primary outcome will be the live birth rate after the embryo transfer.
详细描述
It is postulated that postponing embryo transfer for at least one menstrual cycle after a freeze-all cycle can minimise the possible residual negative effect caused by ovarian stimulation and can promote the resumption of a normal ovulatory cycle and the receptivity of endometrium. Nevertheless, emerging evidence suggests a higher live birth rate in the immediate freeze-all embryo transfer (FET) cycles compared to that in the delayed group. It is unclear the whether postponed FET is superior in hyperresponders. The investigators hypothesize the success rate in the postponed FET for at least one menstrual cycle after oocyte retrieval is higher than in the immediate FET in hyperresponders.
Objective
To evaluate whether the postponed FET for at least one menstrual cycle after oocyte retrieval is superior to the immediate FET in the first menstrual cycle after oocyte retrieval in hyperresponders in terms of live birth rates.
Design: a multicenter, randomised controlled trial Patients: The investigators plan to randomise participants to the immediate FET and the postponed FET from the day of oocyte retrieval to the last day of that menstrual cycle.
Primary outcome: live birth rate after the embryo transfer. Patients who get pregnant will be followed up until 6 weeks after delivery.
Sample size: The investigators plan to enroll 836 participants in a 1:1 rate.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 20 to 42 years old;
- •Written informed consent;
- •Women scheduled for freeze-all embryo transfer;
- •Women with the number of oocyte collected higher than 15.
排除标准
- •Women with a history of at lease three failed transfer cycles;
- •Women with an endometrial thickness less than 7 mm on the triggering day;
- •Severe uterine malformations.
研究组 & 干预措施
Immediate FET group
Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval.
干预措施: the timing of embryo transfer in freeze-all cycles (Biological)
Postponed FET group
Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval.
干预措施: the timing of embryo transfer in freeze-all cycles (Biological)
结局指标
主要结局
Live birth after the first embryo transfer
时间窗: At least 22 months gestation after the first embryo transfer cycle
Live birth is defined as the delivery of at least one baby after 22 weeks of gestation that exhibits any sign of life.
次要结局
- Biochemical pregnancy(about 12 days after embryo transfer)
- Miscarriage(6-22 weeks of gestation)
- Gestational diabetes mellitus(after 24 weeks of gestation)
- Stillbirth(the day of delivery)
- Ectopic pregnancy(about 6 weeks after embryo transfer)
- Gestational hypertension(after 20 weeks of gestation)
- Mode of delivery(the day of delivery)
- Ongoing pregnancy(12 weeks' gestation or beyond after the first embryo transfer cycle)
- Cumulative live birth(6 month after the first embryo transfer)
- Postpartum hemorrhage(the day of delivery)
- Birth weight(the day of delivery)
- Clinical pregnancy(around 7 weeks' gestation after the first embryo transfer cycle)
- Pre-eclampsia(after 20 weeks of gestation)
- Premature rupture of membrane (PROM) rate(the day of delivery)
- Preterm delivery(less than 37 and more than 21 weeks' gestational age)
- Placenta previa(the day of delivery)
研究者
Li Rong
Professor
Peking University Third Hospital