Effects of Korean Red Ginseng on Male Infertility

Study Overview
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Brief Summary
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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
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Male Infertility

Intervention / Treatment
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* Drug: Korean Red Ginseng, Varicocelectomy
* Drug: Placebo
* Procedure: Varicocelectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) |