Effects of Korean Red Ginseng on Male Infertility
Primary Purpose
Male Infertility
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korean Red Ginseng, Varicocelectomy
Placebo
Varicocelectomy
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility
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
Sites / Locations
- Department of Urology, Pusan National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Experimental
Arm Label
non-V + P group
V + P group
non-V + KRG group
V + KRG group
Arm Description
no surgery and placebo (12 weeks)
Surgery with placebo (12 weeks)
no surgery with KRG (korean red ginseng, 1.5 gm daily 12weeks)
Surgery with KRG (1.5 gm daily 12weeks)
Outcomes
Primary Outcome Measures
Sperm concentration
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Sperm motility
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Sperm morphology
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Sperm viability
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
Secondary Outcome Measures
Serum concentrations of FSH
Serum hormonal levels were quantified by chemiluminescence assays
Serum concentrations of LH
Serum hormonal levels were quantified by chemiluminescence assays
Serum concentrations of testosterone
Serum hormonal levels were quantified by radioimmunoassay
Full Information
NCT ID
NCT02202382
First Posted
July 22, 2014
Last Updated
July 29, 2014
Sponsor
Pusan National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02202382
Brief Title
Effects of Korean Red Ginseng on Male Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-V + P group
Arm Type
Placebo Comparator
Arm Description
no surgery and placebo (12 weeks)
Arm Title
V + P group
Arm Type
Active Comparator
Arm Description
Surgery with placebo (12 weeks)
Arm Title
non-V + KRG group
Arm Type
Active Comparator
Arm Description
no surgery with KRG (korean red ginseng, 1.5 gm daily 12weeks)
Arm Title
V + KRG group
Arm Type
Experimental
Arm Description
Surgery with KRG (1.5 gm daily 12weeks)
Intervention Type
Drug
Intervention Name(s)
Korean Red Ginseng, Varicocelectomy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.
Intervention Type
Procedure
Intervention Name(s)
Varicocelectomy
Intervention Description
Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.
Primary Outcome Measure Information:
Title
Sperm concentration
Description
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
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
Title
Sperm motility
Description
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
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
Title
Sperm morphology
Description
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
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
Title
Sperm viability
Description
Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
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
Secondary Outcome Measure Information:
Title
Serum concentrations of FSH
Description
Serum hormonal levels were quantified by chemiluminescence assays
Time Frame
The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
Title
Serum concentrations of LH
Description
Serum hormonal levels were quantified by chemiluminescence assays
Time Frame
The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
Title
Serum concentrations of testosterone
Description
Serum hormonal levels were quantified by radioimmunoassay
Time Frame
The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Urology, Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
12. IPD Sharing Statement
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Effects of Korean Red Ginseng on Male Infertility
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