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Completed

NCT Number: NCT02202382

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.

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Key information

Conditions

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

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of Urology, Pusan National University Hospital

Busan, 602-739, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Korean Red Ginseng, Varicocelectomy

Drug

Placebo

Drug

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

Varicocelectomy

Procedure

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
First posted
Jul 29, 2014
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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