Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Number of mature follicles in the study and control group.
研究概览
简要总结
The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given in individual doses, according to a nomogram we have constructed based on our results from a previous study, results in more patients maturing 2-3 follicles compared to standard dose.
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
- None
入排标准
- 年龄范围
- 25 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 25-39 years
- •First stimulation with rFSH only
- •Indication for intrauterine insemination with standard rFSH starting dose
- •Regular menstrual bleeding with a cycle between 21-35 days
- •Two ovaries
- •Bilateral tuba patency
- •Semen analysis must be sufficient for insemination according to the diagnostic analysis.
排除标准
- •More than three former stimulated intrauterine insemination cycles
研究组 & 干预措施
"Individual" or "standard" rFSH dose
Patients were randomized to recieve "individual" (50, 75 or 100 IU/day) or "standard" (75 IU/day) rFSh dose. The individual dose was prescribed according to a dosage nomogram based on the patient's body weight (kg) and the total antral follicle count (Freiesleben NC et al., RBMOnline 2009;17:632-64).
干预措施: rFSH drug dose (Drug)
"Standard" rFSH dose
"Standard" dose of rFSH
干预措施: "Standard" rFSH dose (Drug)
结局指标
主要结局
Number of mature follicles in the study and control group.
次要结局
- Number of cycles where the rFSH dose is changed.
- Number of cycles cancelled or converted to in vitro fertilisation.
- Pregnancy rate.(October 2008)
研究者
Nina la Cour Freiesleben
MD PhD
Rigshospitalet, Denmark