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Effects of Korean Red Ginseng on Male Infertility

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02202382
First Posted: July 29, 2014
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyun Jun Park, Pusan National University Hospital
  Purpose
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.

Condition Intervention Phase
Male Infertility Drug: Korean Red Ginseng, Varicocelectomy Drug: Placebo Procedure: Varicocelectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hyun Jun Park, Pusan National University Hospital:

Primary Outcome Measures:
  • Sperm concentration [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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:
  • Serum concentrations of FSH [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Enrollment: 80
Study Start Date: April 2011
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: 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.
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)
Drug: Korean Red Ginseng, Varicocelectomy Procedure: Varicocelectomy
Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.

  Eligibility

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202382


Locations
Korea, Republic of
Department of Urology, Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Sponsors and Collaborators
Pusan National University Hospital
  More Information

Responsible Party: Hyun Jun Park, Professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT02202382     History of Changes
Other Study ID Numbers: KGR study
First Submitted: July 22, 2014
First Posted: July 29, 2014
Last Update Posted: July 31, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female