A Randomised Trial to Compare Antral Follicle Count and Serum Anti-Mullerian Hormone Level for Determination of Gonadotrophin Dosing in In-vitro Fertilisation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Having Desired Ovarian Response
研究概览
简要总结
This is a prospective randomized trial to compare the use of AFC and serum AMH as the basis for gonadotrophin dosing in in-vitro fertilization treatment.
The hypothesis is that the use of serum AMH as the criterion for determination of gonadotrophin dosing in IVF treatment results in more optimal ovarian response than AFC.
详细描述
Patients undergoing the first-time IVF treatment cycle using either conventional insemination technique or intracytoplasmic sperm injection at Queen Mary Hospital will be invited to participate in this study. Participating subjects will be randomized into either (i) AFC or (ii) AMH group, where the gonadotrophin dosing will be determined based on the baseline AFC and serum AMH respectively as assessed one month before the IVF treatment. Randomisation will be performed according to a computer-generated list which will be read by an independent research nurse. That research nurse will assign the initial gonadotrophin dose according to the study protocol.
In the AFC group, starting dose of gonadotrophin will be determined based on serum AMH concentration as follows:
AFC <= 5: 300 IU daily AFC >5 and <=15: 225 IU daily AFC >15: 150 IU daily
In the AMH group, starting dose of gonadotrophin will be determined based on serum AMH concentration as follows:
AMH <= 1.0 ng/ml: 300 IU daily AMH >1.0 and <=3.3 ng/ml: 225 IU daily AMH >3.3 ng/ml: 150 IU daily
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing the first IVF cycle during the study period.
排除标准
- •Body mass index >=30 kg/m2
- •Subjects in repeated IVF cycles
- •Subjects undergoing IVF treatment using donor oocytes
- •Subjects undergoing pre-implantation genetic diagnosis
结局指标
主要结局
Percentage of Subjects Having Desired Ovarian Response
时间窗: One single time point, i.e. at the time of oocyte retrieval
Percentage of subjects with number of oocytes retrieved being between 6 and14
次要结局
- Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking(8th day of ovarian stimulation)
研究者
Dr. Hang Wun Raymond Li
Associate Professor
The University of Hong Kong