NCT02307994Unknown4 期
Effectiveness and Safety of uFSH for Severe Oligospermia or Azoospermia:A Multi-center,Open,Randomized,Interventional,and Phase4 Trial in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- testis volume
研究概览
简要总结
The purpose of this study is to determine whether uFSH is effective and safe in the treatment of male patients with severe oligospermia or azoospermia.
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
- None
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged 20~
- •They accorded with diagnostic criteria of severe oligospermia or azoospermia.
- •They had'nt been treated with drug which could improve sperm count and quality one month before observation，otherwise,they should have a elution for 1 month before the study.
排除标准
- •Gram-positive bacteria ,Chlamydia trachomatis,Ureaplasmaurealyticum,or mycoplasma hominis were detected in their semen.
- •Subjects addicted to drug，tobacco，or alcohol.
- •Subjects had heat,chemicals,radioactive material,or toxic contact history within a year.
- •Subjects were under treatment of gonadotropin,anabolic steroid,chemotherapeutic drugs,or nonsteroidal anti-inflammatory drugs .
- •Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease.
- •Subjects were allergic or on uFSH allergy,or under the treatment of other drugs for infertility .
- •Subjects did not meet the inclusion criteria, did not according to the prescribed medication, were unable to judge the efficacy ,had incomplete information, or affected the efficacy or safety judgment.
- •Subjects were IHH patients
研究组 & 干预措施
75IU uFSH
Experimental
75IU uFSH (Livzon Pharm Group Inc., China) being injected into severe oligospermia patients or azoospermia patients every 3 days for 6 months
干预措施: 75IU uFSH (Drug)
结局指标
主要结局
testis volume
时间窗: 6 month
(A + B)grade sperm and sperm activity rate
时间窗: 6 month
A grade sperm
时间窗: 6 month
semen volume
时间窗: 6 month
sex hormone levels
时间窗: 6 month
Sperm density
时间窗: 6 month
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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