Effects of Korean Red Ginseng on Male Infertility

NCT02202382 | Completed Phase 4

• 1 other identifier: KGR study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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 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 concentrations of testosterone

  The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)

Study Arms (4)

non-V + P group

PLACEBO COMPARATOR

no surgery and placebo (12 weeks)

Drug: Placebo

V + P group

ACTIVE COMPARATOR

Surgery with placebo (12 weeks)

Drug: Placebo; Procedure: Varicocelectomy

non-V + KRG group

ACTIVE COMPARATOR

no surgery with KRG (korean red ginseng, 1.5 gm daily 12weeks)

Drug: Korean Red Ginseng, Varicocelectomy

V + KRG group

EXPERIMENTAL

Surgery with KRG (1.5 gm daily 12weeks)

Drug: Korean Red Ginseng, Varicocelectomy; Procedure: Varicocelectomy

Interventions

Korean Red Ginseng, Varicocelectomy DRUG

V + KRG group; non-V + KRG group

Placebo DRUG

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

V + P group; non-V + P group

Varicocelectomy PROCEDURE

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

V + KRG group; V + P group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Department of Urology, Pusan National University Hospital

Busan, 602-739, South Korea

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 29, 2014
• Study Start: April 1, 2011
• Primary Completion: January 1, 2012
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

KR (1)