Optimal Timing of Euploid Day 6 Blastocyst (Blastocyst Which Was Biopsied on Day 6 After Fertilization) Transfer in Frozen Hormonal Replacement Therapy Cycles: Day 6 or Day 7 of Progesterone Administration?
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 316
- 试验地点
- 4
- 主要终点
- Livebirth rate (LBR)
研究概览
简要总结
The goal of this study is to compare the difference in clinical pregnancy, miscarriage and livebirth rate between day 6 euploid blastocyst transfer on the 6th and the 7th day of progesterone exposure in Hormonal Replacement Therapy (HRT) FET cycles. This prospective & randomized study will only include euploid day 6 blastocysts. This will be the first prospective study of euploid day 6 blastocysts thereby excluding aneuploidy as a cause of miscarriage and implantation failure. The point of randomization will occur on the day of progesterone commencement.
详细描述
Traditionally the duration of progesterone exposure before embryo transfer has been considered equal for day 5 and day 6 embryos but this may not be the case and warrants further study. The optimal preparation of the endometrium in frozen embryo transfer (FET) cycles is yet to be determined. Synchronization between the embryonic stage and the endometrial window of implantation (WOI) is crucial and progesterone plays a critical role in the WOI (1). Data on the optimal route of administration, the dose and duration of progesterone supplementation before blastocyst transfer are inconsistent (2,3). In view of the current lack of evidence, this study will be of importance.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 years to 43 years.
- •Having at least 1 euploid cryopreserved day 6 blastocyst of at least Grade BB quality.
- •Endometrial trilaminar appearance on the day of progesterone start
排除标准
- •Uterine abnormality
- •Hydrosalpinx
- •Asherman syndrome
- •Any known contraindications or allergy to oral estradiol or progesterone.
- •Intention to treat : exclusion factors :
- •Spontaneous ovulation HRT cycle
- •Discontinuation of HRT medication
研究组 & 干预措施
Group B
Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
干预措施: Transvaginal ultrasound (Diagnostic Test)
Group B
Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
干预措施: Embryo transfer (Procedure)
Group B
Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
干预措施: Serum P4 day of ET (Diagnostic Test)
Group A
Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
干预措施: Embryo transfer (Procedure)
Group A
Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
干预措施: Progesterone 100 Mg Vaginal Insert (Drug)
Group A
Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
干预措施: Transvaginal ultrasound (Diagnostic Test)
Group A
Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
干预措施: Serum LH, E2, P4 (Diagnostic Test)
Group A
Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
干预措施: Estradiol Valerate 2 MG (Drug)
Group A
Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
干预措施: Serum P4 day of ET (Diagnostic Test)
Group B
Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
干预措施: Serum LH, E2, P4 (Diagnostic Test)
Group B
Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
干预措施: Estradiol Valerate 2 MG (Drug)
Group B
Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
干预措施: Progesterone 100 Mg Vaginal Insert (Drug)
结局指标
主要结局
Livebirth rate (LBR)
时间窗: 41 weeks
Defined as the delivery of a live infant born after 24 completed weeks of gestation
次要结局
- Clinical pregnancy rate(5 weeks)
- Biochemical pregnancy rate(5 weeks)
- Ongoing pregnancy rate after 12 weeks(13 weeks)
- Miscarriage rate(24 weeks)