CTRI/2010/091/000574未知不适用
An Open, Prospective, Double Blind, Randomised, Multicentre Study to Assess the Safety and Efficacy of Paternia in Male Infertility
未提供5 个研究点 分布在 1 个国家目标入组 140 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI), Fertilization potential by HOS test
研究概览
简要总结
This study is an randomized, double blind, comparative, multicentric placebo controlled study comparing the safety and efficacy of two dosage schedules of Paternia tablets as one tablet twice daily or two tablets twice daily each for 360 days in 140 male patients with infertility that will be conducted in five centers in India. The primary outcome measures will be the improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI) and fertilization potential by HOS test.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
入选标准
- •1.Age between 21 to 50 years2.Sperm count ?
- •< 50 million/cu mm3.Sperm motility < 50 % (according to World Health Organization [WHO] 1999 criteria)4.Normal Sperm morphology < 50 %5.No history of taking therapy for infertility6.No history of obstructive azoospermia 7.Normal female partner8.Willing to sign Informed consent9.Subjects likely to be available for all visits during follow-up period.
排除标准
- •1.Any organic cause for male factor infertility2.Prostato-vesiculo-epididymitis 3.Not planning for IVF etc in the proposed study period4.Abnormal hormonal profile: gonadotropins, T, E 2, and PRL, FSH>155.Presence of antispermatozoa antibodies6.Severe oligospermia 7.Varicocoele8.Azoospermia 9.Presence of infectious genital diseases10.Seminal white blood cells (WBCs) more than 1 x 10 6/mL11.Major hepatic and Renal disease12.Myopathy 13.Primary testicular diseaease14.Subject with history of allergy to any ingredient of the formulation15.Subject not likely to be available for follow-up.16.Participation in another clinical trial in the past 3 months.
结局指标
主要结局
Improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI), Fertilization potential by HOS test
时间窗: Day 0, 90, 180, 270 & 360
次要结局
- Pregnancy Rate(Day 0, 30, 60, 90, 180, 270 & 360)
研究者
研究点 (5)
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