NCT01319695已完成1 期
Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- no of oocytes (>2 between groups)
研究概览
简要总结
The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation protocols in women undergoing in vitro fertilisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-36 years old with a body weight of more than 60 kg up to 90 kg
- •BMI of 18-32 kg/m2
- •Menstrual cycle length of 23-35 days
- •An indication for controlled ovarian stimulation for IVF or ICSI
排除标准
- •history of an endocrine abnormality
- •abnormal outcome of blood biochemistry or hematology
- •abnormal cervical smear
- •chronic disease
- •uterine pathology that interfering with the COS treatment (e.g. fibroids ≥ 5 cm)
研究组 & 干预措施
corifollitropin alfa
Experimental
干预措施: corifollitropin alfa (Drug)
recombinant follicle stimulating hormone (FSH)
Active Comparator
150-300 IU of FSH for ovarian stimulation in women undergoing IVF
干预措施: recombinant follicle stimulating hormone (FSH) (Drug)
结局指标
主要结局
no of oocytes (>2 between groups)
时间窗: at egg recovery, through study completion, an average of 2 years
次要结局
- Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate(3 weeks after embryo transfer)
- Ongoing pregnancy rate(12 weeks after embryo transfer)
- miscarriage rate(through study completion, an average of 2 years)
- live birth rate(through study completion, an average of 2 years)
研究者
Siristatidis Charalampos, MD, PhD
Assistant Professor, Director of the ARU
National and Kapodistrian University of Athens
研究点 (2)
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