NCT00575302撤回4 期
Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
Centre Hospitalier Chretien8 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2007年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- number of mature oocytes
研究概览
简要总结
In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.
详细描述
Women > 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:
300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
Patient can be eligible for several cycles in same protocol.
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
- 38 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women > 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.
- •Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
- •Patient can be eligible for several cycles in same protocol.
排除标准
- •Patients who already received doses > 225 IU
- •Patients older than 42 years
- •Patients with basal FSH concentrations ≥ 15 mU/ml at day 3
结局指标
主要结局
number of mature oocytes
时间窗: 1 month
次要结局
- follicular development(1 month)
- fertilization rate(1 month)
- implantation rate(1 month)
- embryo quality(1 month)
- pregnancy rate(1 month)
研究者
研究点 (8)
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