Effects of Korean Red Ginseng on Male Infertility
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sperm concentration
研究概览
简要总结
Objective: Several in vitro studies report positive effects of ginseng on spermatogenesis. However, no controlled human clinical study of the effect of Korean red ginseng (KRG) on spermatogenesis has been performed. This study was performed to investigate the effects of KRG on semen parameters in male infertility patients in a randomized, double-blind, placebo-controlled study. Methods: A total of 80 male infertility patients with varicocele were recruited from April 2011 to February 2012. The subjects were then divided into the following four groups: non-V + P group, placebo; V + P group, placebo and varicocelectomy; non-V + KRG group, 1.5-g KRG daily; V + KGR group, 1.5-g KRG daily and varicocelectomy. Semen analysis was performed and hormonal levels were measured in each treatment arm after 12 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients should be males, 25 - 45 years of age
- •Complained of infertility for at least 12 months
- •No history of surgical or medical treatments for infertility
- •Increased retrograde flow in the internal spermatic vein with venous diameter > 3 mm during the Valsalva maneuver on scrotal ultrasonography was used as an indicator of varicocele.13 Varicocele was graded according to the criteria presented by Lyon et al.14: grade I, palpable only with the Valsalva maneuver; Grade II, palpable without the Valsalva maneuver; Grade III, visible from a distance.
排除标准
- •The exclusion criteria were as follows:
- •A history of vasectomy or obstructive azoospermia
- •Chromosomal abnormalities
- •Hypogonadism or pituitary abnormalities
- •Anatomical abnormality of the genitals
- •Significant hepatopathy (liver enzymes elevated 2 - 3-fold higher than the normal range)
- •Renal insufficiency (serum creatinine level > 2.5 mg/dL)
- •Medical treatment for infertility during the past 4 weeks
研究组 & 干预措施
non-V + P group
no surgery and placebo (12 weeks)
干预措施: Placebo (Drug)
V + P group
Surgery with placebo (12 weeks)
干预措施: Placebo (Drug)
V + P group
Surgery with placebo (12 weeks)
干预措施: Varicocelectomy (Procedure)
non-V + KRG group
no surgery with KRG (korean red ginseng, 1.5 gm daily 12weeks)
干预措施: Korean Red Ginseng, Varicocelectomy (Drug)
V + KRG group
Surgery with KRG (1.5 gm daily 12weeks)
干预措施: Korean Red Ginseng, Varicocelectomy (Drug)
V + KRG group
Surgery with KRG (1.5 gm daily 12weeks)
干预措施: Varicocelectomy (Procedure)
结局指标
主要结局
Sperm concentration
时间窗: When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Sperm motility
时间窗: When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Sperm morphology
时间窗: When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Sperm viability
时间窗: When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
次要结局
- Serum concentrations of FSH(The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment))
- Serum concentrations of LH(The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment))
- Serum concentrations of testosterone(The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment))
研究者
Hyun Jun Park
Professor
Pusan National University Hospital