Effects of Korean Red Ginseng on Male Infertility

• ClinicalTrials.gov Identifier: NCT02202382
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Last Update Posted: July 31, 2014
• Sponsor: Pusan National University Hospital
• Information provided by (Responsible Party): Hyun Jun Park, Pusan National University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Male Infertility	Drug: Korean Red Ginseng, Varicocelectomy; Drug: Placebo; Procedure: Varicocelectomy	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: April 2011
• Actual Primary Completion Date: January 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Sperm concentration [ Time Frame: 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)
2. Sperm motility [ Time Frame: 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)
3. Sperm morphology [ Time Frame: 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)
4. Sperm viability [ Time Frame: 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 Outcome Measures :

1. Serum concentrations of FSH [ Time Frame: 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
2. Serum concentrations of LH [ Time Frame: 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
3. Serum concentrations of testosterone [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Department of Urology, Pusan National University Hospital

Busan, Korea, Republic of, 602-739

Sponsors and Collaborators

Pusan National University Hospital

More Information

• Responsible Party: Hyun Jun Park, Professor, Pusan National University Hospital
• ClinicalTrials.gov Identifier: NCT02202382
• Other Study ID Numbers: KGR study
• First Posted: July 29, 2014
• Last Update Posted: July 31, 2014
• Last Verified: July 2014

Additional relevant MeSH terms:

Infertility; Infertility, Male