Clinical trial NCT02204826: Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
Official title: Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Male Infertility
Keywords: Effects of Korean Red Ginseng on semen parameters in male infertility patients: a randomized, placebo-controlled, double-blind clinical study
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2014-07-30
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: Korean Red ginseng (KRG) has long been applied to various diseases as a health-promoting herbal medicine in Korea. Many clinical studies of ginseng have been performed to elucidate its therapeutic characteristics. KRG has been shown to be effective in many diseases, such as cancers, hypertension, Alzheimer's disease, diabetes, acquired immune deficiency syndrome, and sexual dysfunction. Several studies have indicated effects of ginseng on improving spermatogenesis in animals. The major mechanisms behind these effects were speculated to be anti-oxidant and anti-aging effects, as well as modulation of the hypothalamus-pituitary-testis axis \[7 - 10\]. However, there have been no controlled human clinical trials to evaluate the effects of KRG on spermatogenesis in patients with male infertility.

Only a small proportion of causes of male infertility are currently curable, including male hypogonadal disorders that can be cured by gonadotropic agents, and obstructive azoospermia that can be corrected by surgery. In addition, evidence-based medicine has revealed that most empirical treatments are ineffective. Similarly, the efficacies of carnitine, anti-estrogens, kallikrein, vitamins C and E, and glutathione have not been confirmed.

Therefore, the investigators investigated the effects of KRG on semen parameters in male infertility patients. This is the first placebo-controlled trial to evaluate the therapeutic effects of KRG in male patients.


Eligibility criteria: Inclusion Criteria:

* Patients should be males, 25 - 45 years of age, who had complained of infertility for at least 12 months, and had 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:

* 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: Semen parmaters change from baseline to post-treatment
timeFrame: Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)
Secondary outcomes:
measure: Changes in hormonal parameters after treatment
timeFrame: Before treatment, After 14 weeks (12 week treatment and 2 week wash out periond)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of Urology, Pusan National University Hospital
Study officials:
affiliation: Department of Urology, Pusan National University Hospital
name: Hyun Jun Park, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: