Clinical trial NCT02202382: Effects of Korean Red Ginseng on Male Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Male Infertility
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 80
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Sperm concentration
timeFrame: 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
measure: Sperm motility
timeFrame: 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
measure: Sperm morphology
timeFrame: 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
measure: Sperm viability
timeFrame: 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:
measure: Serum concentrations of FSH
timeFrame: The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
measure: Serum concentrations of LH
timeFrame: The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
measure: Serum concentrations of testosterone
timeFrame: The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of Urology, Pusan National University Hospital
Study officials:
References: