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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.
Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.
Department of Urology, Pusan National University Hospital
Busan, South Korea
Sperm concentration
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Time frame: 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
Sperm motility
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Time frame: 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
Sperm morphology
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Time frame: 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
Sperm viability
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Time frame: 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
Serum concentrations of FSH
Serum hormonal levels were quantified by chemiluminescence assays
Time frame: 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
Serum hormonal levels were quantified by chemiluminescence assays
Time frame: 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
Serum hormonal levels were quantified by radioimmunoassay
Time frame: The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
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