Effects of Korean Red Ginseng on Male Infertility

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 Overview

• Status: Completed
• Conditions: Male Infertility
• Intervention / Treatment: Procedure: Varicocelectomy; Drug: Placebo; Drug: Korean Red Ginseng, Varicocelectomy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Department of Urology, Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: non-V + P group; no surgery and placebo (12 weeks)	Drug: Placebo; Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.
Active Comparator: V + P group; Surgery with placebo (12 weeks)	Procedure: Varicocelectomy; Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.; Drug: Placebo; Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.
Active Comparator: non-V + KRG group; no surgery with KRG (korean red ginseng, 1.5 gm daily 12weeks)	Drug: Korean Red Ginseng, Varicocelectomy
Experimental: V + KRG group; Surgery with KRG (1.5 gm daily 12weeks)	Procedure: Varicocelectomy; Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.; Drug: Korean Red Ginseng, Varicocelectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm concentration	Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)	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)	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)	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentrations of FSH	Serum hormonal levels were quantified by chemiluminescence assays	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	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	The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)

Collaborators and Investigators

• Sponsor: Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 29, 2014

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: KGR study