Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study

Phase 4

Completed

• Conditions: Male Infertility
• Interventions: Drug: Korean Red Ginseng (KRG); Procedure: Varicocelectomy

• Registration Number: NCT02204826
• Lead Sponsor: Pusan National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-02
• Study Completion: 2013-12
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-V + KRG group	Korean Red Ginseng (KRG)	three capsules of KRG (500 mg/dose) daily
non-V + P group	Korean Red Ginseng (KRG)	non-V + P group (n = 20) placebo capsules
V + KRG group (n = 20)	Korean Red Ginseng (KRG)	three capsules of KRG (500 mg/dose) daily and varicocelectomy.
V + KRG group (n = 20)	Varicocelectomy	three capsules of KRG (500 mg/dose) daily and varicocelectomy.
V + P group (n = 20)	Varicocelectomy	placebo capsules and varicocelectomy

Primary Outcome Measures

Name	Time	Method
Semen parmaters change from baseline to post-treatment	Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)	1) sperm concentration, 2) percent motility, 3) sperm viability, and 4) Kruger/strict morphology using World Health Organization (WHO) methodologies (4th edition).

Secondary Outcome Measures

Name	Time	Method
Changes in hormonal parameters after treatment	Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)	Serum concentrations of FSH and LH were measured using chemiluminescence assays, and serum total testosterone was quantified by radioimmunoassay. The hormonal status of all patients was recorded at the initial screening visit and post-treatment.

Trial Locations

Locations (1)

Department of Urology, Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of