NCT03588949Unknown不适用
Role of Nutritional Support in Idiopathic Male Infertility: a Randomized Dietary Study
NATURAmedicatrix Sàrl2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rate of normalization of spermogram
研究概览
简要总结
Approximately 100 males with idiopathic infertility and oligo- and/or astheno- and/or and/or teratozoospermia and fertile woman will take a Test dietary supplement (TDS), containing carnitine, vitamins and trace elements (active group) or carotene (control group) for 6 months (50 subjects in active and control groups). Before intake, and 2 and 4 months after the commencement of TDS, all males will have spermogram. After 6-month use of the TDS and during the 12th month of the study, couples will be screened for conception, pregnancy, and a newborn
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent form signed;
- •Age: 21-50;
- •Idiopathic male infertility;
- •Idiopathic oligo- and/or astheno- and/or teratozoospermia;
- •Stated availability throughout the study period and a mobile phone
排除标准
- •Allergy to any component of the dietary supplement;
- •Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of male infertility;
- •Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of female infertility;
- •Inflammatory bowel disease;
- •Known moderate to severe disease of any systems;
- •Known or suspected sexually transmitted diseases;
- •Alcohol or drug addiction of any couple counterpart as suspected by investigator;
- •Difficulty to comprehend study requirements as judged by investigator;
- •Use of any investigational product within the previous 3 months before entering the study;
- •Use of any drugs that stimulate or suppress spermatogenesis within previous 3 months
结局指标
主要结局
Rate of normalization of spermogram
时间窗: 4 months
None deviation found in spermogram
次要结局
未报告次要终点
研究者
研究点 (2)
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