NCT00975117已完成3 期
Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Parameters of seminal analysis at weeks 24
研究概览
简要总结
The purpose of this study is to determine whether the administration of the dietary supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility unrelated to major testicular conditions. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with infertility to be recruited and randomized for the study is 86.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male infertility unrelated to major testicular conditions
- •Must have at least one altered seminal parameter.
- •Signed informed consent
排除标准
- •Hydrocele, varicocele, orchitis, epididymitis, irradiation or Chemotherapy.
- •Previously treated and cured testicular condition.
- •Non-transmissible chronic diseases
- •Use of antioxidant agents within 6 months.
- •Use of vitamins within 6 months.
- •Use of anti-inflammatory drugs within 6 months.
- •Use of hormones prescribed by an andrologist within 6 months
- •Positive serology/HIV
- •Leukocytospermia
结局指标
主要结局
Parameters of seminal analysis at weeks 24
时间窗: 24 weeks
次要结局
- Fertilization achievement(24 weeks)
- Presence of mild or severe adverse effects(24 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer CachexiaWeight LossGastrointestinal CancerLung CancerCancer CachexiaNCT04131426University of Rochester25
已完成
不适用
An Exploratory Investigation of Dietary Supplementation and Its EffectQuality of LifeNCT05037877HUM Nutrition, Inc.110
Unknown
不适用
Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate HyperlipidemiaChronic SmokersHyperlipidemiaNCT02100202Olive Lifesciences Pvt Ltd60
Unknown
不适用
Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate HyperlipidemiaChronic SmokersHyperlipidemiaNCT02203227Olive Lifesciences Pvt Ltd60
已完成
不适用
Clinical Study to Assess a Dietary Supplement on Sleep Health and QualitySleep QualitySleep HealthNCT053689094Life Research, LLC30