Effects of GINST on Human Semen
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Semen quality (assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis)
研究概览
简要总结
The purpose of the study is to evaluate the effect of GINST on human semen. The study is a pilot study, designed as open-label, prospective randomized clinical trial using GINST either 500mg/capsule (panax ginseng 0.96g/day) or 1000mg/capsule (panax ginseng 1.92g/day), two capsules at once, three times a day for 12 weeks. GINST(Ilhwa, Republic of Korea) is a dietary supplement capsule, which is made with 6 year-old Korean red ginseng (Panax ginseng). Expected participants are to be male partners of female patients who visit infertility clinic at Severance hospital, whose total motile sperm count is more than 0.5x106 by semen analysis using computer aided sperm analyzer (CASA). Semen analysis, blood test, questionaires are planned to be performed 2 times, on the initial visit and after 12weeks of GINST treatment. Semen analysis will reveal ejaculated volume, sperm count, motility, morphology, total leukocyte count, total motile sperm count, further analysis including sperm chromatin assessment to examine the quality of sperm and malondialdehyde (MDA) analysis of seminal fluid to assess oxidative stress will be performed. Blood test will be done including serum follicle stimulating hormone (FSH), luteinizing hormone (LH), total and free testosterone. Quality of life, sexual performance before and after taking GINST will be evaluated using questionaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •partner of female patient who visit infertility clinic with chief complaint of infertility.
- •≥0.5x106 of total motile sperm count on screening semen analysis.
排除标准
- •Those who have chronic, systemic disease or endocrinologic disorder.
- •Patients with hypertension (systolic blood pressure ≥ 140mmHg, diastolic blood pressure ≥ 90mmHg)
- •Patients who have undergone chemotherapy due to malignancy
- •Patient who has history of taking testosterone or anti androgen agents within 1 month.
- •Patient who has retrieved sperm surgically
研究组 & 干预措施
Low group
GINST15 3g/day
干预措施: GINST (Dietary Supplement)
High group
GINST15 6g/day
干预措施: GINST (Dietary Supplement)
结局指标
主要结局
Semen quality (assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis)
时间窗: 12 week
Semen quality assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis
次要结局
- Quality of Life (SF-36, Brief sexual function inventory, fatigue severity scale)(12 week)
- serum hormones (serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone)(12 week)