Male Infertility
Conditions
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.
Interventions
DRUGKorean Red Ginseng, Varicocelectomy
DRUGPlacebo
Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.
PROCEDUREVaricocelectomy
Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.
Sponsors
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
25 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm concentration | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 hormonal levels were quantified by chemiluminescence assays |
| 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) | Serum hormonal levels were quantified by radioimmunoassay |
| 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 hormonal levels were quantified by chemiluminescence assays |
Countries
South Korea
Outcome results
None listed