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Effects of Korean Red Ginseng on Male Infertility

NCT ID: NCT02202382

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Male Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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non-V + P group

no surgery and placebo (12 weeks)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.

V + P group

Surgery with placebo (12 weeks)

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.

Varicocelectomy

Intervention Type PROCEDURE

Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.

non-V + KRG group

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

Group Type ACTIVE_COMPARATOR

Korean Red Ginseng, Varicocelectomy

Intervention Type DRUG

V + KRG group

Surgery with KRG (1.5 gm daily 12weeks)

Group Type EXPERIMENTAL

Korean Red Ginseng, Varicocelectomy

Intervention Type DRUG

Varicocelectomy

Intervention Type PROCEDURE

Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.

Interventions

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Korean Red Ginseng, Varicocelectomy

Intervention Type DRUG

Placebo

Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.

Intervention Type DRUG

Varicocelectomy

Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun Jun Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Urology, Pusan National University Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KGR study

Identifier Type: -

Identifier Source: org_study_id