Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
Korean Red ginseng (KRG) has long been applied to various diseases as a health-promoting
 herbal medicine in Korea. Many clinical studies of ginseng have been performed to elucidate
 its therapeutic characteristics. KRG has been shown to be effective in many diseases, such as
 cancers, hypertension, Alzheimer's disease, diabetes, acquired immune deficiency syndrome,
 and sexual dysfunction. Several studies have indicated effects of ginseng on improving
 spermatogenesis in animals. The major mechanisms behind these effects were speculated to be
 anti-oxidant and anti-aging effects, as well as modulation of the
 hypothalamus-pituitary-testis axis [7 - 10]. However, there have been no controlled human
 clinical trials to evaluate the effects of KRG on spermatogenesis in patients with male
 infertility.

 Only a small proportion of causes of male infertility are currently curable, including male
 hypogonadal disorders that can be cured by gonadotropic agents, and obstructive azoospermia
 that can be corrected by surgery. In addition, evidence-based medicine has revealed that most
 empirical treatments are ineffective. Similarly, the efficacies of carnitine, anti-estrogens,
 kallikrein, vitamins C and E, and glutathione have not been confirmed.

 Therefore, the investigators investigated the effects of KRG on semen parameters in male
 infertility patients. This is the first placebo-controlled trial to evaluate the therapeutic
 effects of KRG in male patients.
Inclusion Criteria:

 -  Patients should be males, 25 - 45 years of age, who had complained of infertility for
 at least 12 months, and had 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.

 Exclusion Criteria:

 -  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.