Effects of Korean Red Ginseng on Male Infertility

Phase 4

Completed

• Conditions: Male Infertility
• Interventions: Drug: Placebo; Drug: Korean Red Ginseng, Varicocelectomy; Procedure: Varicocelectomy

• Registration Number: NCT02202382
• Lead Sponsor: Pusan National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-01
• Status Verified: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-29
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

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

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V + P group	Placebo	Surgery with placebo (12 weeks)
non-V + KRG group	Korean Red Ginseng, Varicocelectomy	no surgery with KRG (korean red ginseng, 1.5 gm daily 12weeks)
V + KRG group	Korean Red Ginseng, Varicocelectomy	Surgery with KRG (1.5 gm daily 12weeks)
V + KRG group	Varicocelectomy	Surgery with KRG (1.5 gm daily 12weeks)
non-V + P group	Placebo	no surgery and placebo (12 weeks)
V + P group	Varicocelectomy	Surgery with placebo (12 weeks)

Primary Outcome Measures

Name	Time	Method
Sperm concentration	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	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	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	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)

Secondary Outcome Measures

Name	Time	Method
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 hormonal levels were quantified by chemiluminescence assays
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 hormonal levels were quantified by chemiluminescence assays
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)	Serum hormonal levels were quantified by radioimmunoassay

Trial Locations

Locations (1)

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