The Effect of Serum Progesterone Level on Day 3 in HRT-FET Cycles on the Clnical Outcome: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 423
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
In the window of implantation, progesterone plays an important role. Sufficient serum progesterone is basic for ongoing pregnancy. Vaginal progesterone is more and more widely used in ART. As it has no hepatic first pass effect. What is the optimal serum level for pregnancy when use vaginal progesterone is not known yet? Hormone replacement therapy- FET is the optimal strategy to explore this question. There are some retrospective studies showed that the serum progesterone level on embryo transfer day (D3 or D5) or pregnancy test day (D14) lower than 10-11ng/ml is significantly associated with ongoing pregnancy rate in HRT-FET cycles. This prospective study is designed to compare the ongoing pregnancy rate between different serum progesterone levels on D3 and to explore the intervention of additional progesterone supplement since D3 is helpful in HRT-FET cycles.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HRT-FET cycles，including GnRHa-HRT-FET
- •Age<41 years old
- •BMI<30kg/m2
- •TSH and PRL normal
- •Endometrium thickness ≥8mm on D0 6） embryo transfer completed with at least 1 top-quality embryo (7-9 cell Grade 1 or D5 beyond grade 3 ) 7） Scandalized luteal phase support： transvaginal progesterone 0.2 tid with or without oral progesterone 10mg bid 8） included once for every patient
排除标准
- •history of Moderate and Severe uterine adhesion；
- •presence of hydrosapinx diameter >2cm
- •Endometrosis at stage III-IV
- •Recurrent implantation failure (>3 times of embryo transfer cycle)
研究组 & 干预措施
A1
The included patient should test serum progesterone level on D3 no matter which day perform the embryo transfer. According to the progesterone level, there are two groups, Group A: serum progesterone <7.24ug/L, followed by randomized A1: plus additional treatment（intramuscular progesterone 20-40mg from D3 ）
干预措施: intramuscular progesterone 20-40mg from D3 until pregnancy test (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 10 weeks after embryo transfer
beyond pregnancy week 12 in HRT-FET cycles
次要结局
- Clinical pregnancy rate(10 weeks after embryo transfer)
研究者
Haiyan Lin
Principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University