NCT04751084进行中（未招募）不适用
Use of Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment With High and Low Uterine Contraction Frequency Prior to Embryo Transfer: A Prospective Double-blinded Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 675
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
To determine if the use of Buscopan in patients undergoing IVF/ICSI treatment with high uterine contraction frequency prior to embryo transfer has a higher live birth rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
double blinded to the randomization list
入排标准
- 年龄范围
- — 至 42 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing embryo transfer in either fresh or frozen cycles
排除标准
- •Women aged > 42 years old
- •Women with factors which will affect uterine contractility
- •congenital uterine anomaly
- •acquired uterine pathology such as myoma >5cm, adenomyosis >5cm or endometrial polyp
- •Women with presence of hydrosalpinx
- •Women undergoing pre-implantation genetic test in IVF cycles
- •History of allergy to misoprostol , Buscopan® or same group of drug
- •Contraindication to the use of Buscopan® e.g. glaucoma, myasthenia gravis, tachycardia, megacolon
- •Women who are on other smooth muscle relaxant other than Buscopan®
研究组 & 干预措施
treatment group
Active Comparator
20mg Buscopan intravenous will be given 5 minutes prior to embryo transfer
干预措施: Buscopan 20 milligrams/ML Injectable Solution (Drug)
control group
Placebo Comparator
2ml Normal Saline intravenous will be given 5 minutes prior to embryo transfer
干预措施: Buscopan 20 milligrams/ML Injectable Solution (Drug)
结局指标
主要结局
live birth rate
时间窗: after 24 weeks of gestation
live baby born
次要结局
- implantation rate(8-10 days after embryo transfer)
- clinical pregnancy rate(at 6 weeks gestation)
- multiple pregnancy rate(after 24 weeks of gestation)
- miscarriage rate(before 24 weeks of gestation)
- ectopic pregnancy rate(at 6-7 weeks of gestation)
研究者
Mak Sze Man Jennifer
Associate Professor
Chinese University of Hong Kong
研究点 (1)
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