Effects of Korean Red Ginseng on Male Infertility

Pusan National University

Status and phase: Completed; Phase 4

Conditions: Male Infertility

Treatments: Drug: Korean Red Ginseng, Varicocelectomy; Procedure: Varicocelectomy; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02202382

KGR study

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

non-V + P group

Placebo Comparator group

Description:

no surgery and placebo (12 weeks)

Treatment:

Drug: Placebo

V + P group

Active Comparator group

Description:

Surgery with placebo (12 weeks)

Treatment:

Drug: Placebo

Procedure: Varicocelectomy

non-V + KRG group

Active Comparator group

Description:

no surgery with KRG (korean red ginseng, 1.5 gm daily 12weeks)

Treatment:

Drug: Korean Red Ginseng, Varicocelectomy

V + KRG group

Experimental group

Description:

Surgery with KRG (1.5 gm daily 12weeks)

Treatment:

Procedure: Varicocelectomy

Drug: Korean Red Ginseng, Varicocelectomy