Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ovarian Response
研究概览
简要总结
Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.
详细描述
Patients will be randomized using sealed and numbered envelopes and will be assigned to receive a similar ovarian stimulation regime incorporating either Gonal-F or highly purified Fostimon as the hormonal analog. Ovarian response using either of the two compounds, pregnancy rates and miscarriage rates will be compared to define possible statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primary infertility
- •No other fertility manifestation
排除标准
- •Secondary infertility
研究组 & 干预措施
gonadotropin
recombinant or highly purified gonadotropin
干预措施: Gonal-F, Fostimon (Drug)
Gonadotropins
recombinant versus highly purified gonadotropin
干预措施: Gonal-F, Fostimon (Drug)
结局指标
主要结局
Ovarian Response
时间窗: 0-15 days post gonadotropin administration
次要结局
- Pregnancy rate(12-15 days post embryo replacement)