Effects of Korean Red Ginseng on Male Infertility

Male Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202382
• Other study ID #: KGR study
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2014
• Last updated: July 29, 2014
• Start date: April 2011

Study information

• Verified date: July 2014
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Drug:
• Korean Red Ginseng, Varicocelectomy

• Placebo
Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.

Procedure:
• Varicocelectomy
Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology, Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No