A Randomized Double Blind Controlled Comparison of Oral Dydrogesterone as Luteal Phase Support in Natural Cycle Frozen-thawed Embryo Transfer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 716
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
This randomised double-blinded controlled trial aims to compare the live birth rate in natural FET cycles with and without oral dydrogesterone as luteal phase support. The hypothesis is that the use of oral dydrogesterone will increase the live birth rate of natural cycle FET.
详细描述
Trial design:
Women undergoing FET in the Centre of Assisted Reproduction and Embryology, The University of Hong Kong-Queen Mary Hospital, will be recruited and will be randomized into one of the following two study groups:
Treatment group: Oral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation.
Control group: Placebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation.
Treatment of subjects
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age of women <43 years at the time of stimulated IVF
- •Replacing early cleavage embryos or blastocysts after thawing
排除标准
- •Requiring hormonal replacement cycles
- •Use of donor oocytes or embryos
- •Undergoing preimplantation genetic testing
- •Presence of hydrosalpinx not corrected surgically prior to FET
- •Refusal to join the study
研究组 & 干预措施
Dydrogesterone group
Oral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation.
干预措施: Dydrogesterone (Drug)
Placebo group
Placebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation.
干预措施: Placebo (Drug)
结局指标
主要结局
live birth rate
时间窗: 10 months after recruitment
the number of live birth beyond 22 weeks gestation per transfer cycle
次要结局
- Ongoing pregnancy rate(10 weeks of gestation after recruitment)
- Clinical pregnancy rate(6 weeks of gestation after recruitment)
- Pregnancy loss per number of transfer cycles(less than 22 weeks of gestation)