Effect of Fermented Ginseng (GINST) on Sperm Motility

Not Applicable

• Conditions: Asthenozoospermia
• Interventions: Dietary Supplement: fermented ginseng (GINST); Dietary Supplement: Placebo

• Registration Number: NCT03183999
• Lead Sponsor: Jae Hoon Lee

Brief Summary

This randomized, double-blind, placebo-controlled study aimed to evaluate the effect of ginseng(GINST) supplementation for 12 weeks on sperm motility.

Detailed Description

This multicenter, randomized, double-blind, placebo-controlled clinical trial was aimed to evaluate of sperm motility improvement effect of fermented ginseng(GINST). Experimental arm and control arm were randomly assigned among the volunteers who met the inclusion criteria: men between the ages of 18 and 60 who had sperm motility of less than 32%.

To experimental arm, capsules including 160mg of fermented ginseng(GINST) ingredients will be provided for 12 weeks. To control arm, capsules of the same shape and weight as GINST capsules will be provided. These capsules are made of a cellulose component.

Primary outcome is sperm motility. Secondary outcome are \<Brief Male Sexual Function Inventory\> , \<Fatigue Severity Scale\>, and \<the Short Form (36) Health Survey\> measured at baseline and end of the trial.

Study Timeline

• Study Start: 2017-01-26
• Study First Submitted: 2017-05-17
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-09
• Last Update Submitted: 2017-06-09
• Study First Posted: 2017-06-12
• Last Update Posted: 2017-06-12
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Male between 18 and 60 years old
• Men who have agreed to participate in this trial before the start of the study and who have written an informed consent

Exclusion Criteria

• Those who are diagnosed and treated for hypertension (systolic blood pressure> 140mmHg and diastolic blood pressure> 90mmHg)
• Patients with a history of chemotherapy for malignant tumors
• Patients with a history of taking testosterone or antiandrogens within 1 month
• BMI> 30 or BMI <18
• Those who have the following results in the blood test: AST(aspartate aminotransferase ), ALT(Alanine transaminase) > 2 times the upper limit of reference range; Serum Creatinine> 2.0 mg / dl
• Those who ingested drugs (eg, folic acid, L-carn, HCG(human chorionic gonadotropin ), FSH(Follicle-stimulating hormone), Clomiphene, etc.) that have an effect on sperm motility within 2 weeks before the screening day.
• Persons who have received antipsychotic medication within 2 months before the screening test
• Those who have history of alcoholism or substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GINST group	fermented ginseng (GINST)	Experimental group was randomly assigned among the volunteers who met the inclusion criteria: men between the ages of 18 and 60 who had sperm motility of less than 32%. Fermented ginseng (GINST) was supplied.
Control group	Placebo	Control group was randomly assigned among the volunteers who met the inclusion criteria: men between the ages of 18 and 60 who had sperm motility of less than 32%. Placebo was supplied.

Primary Outcome Measures

Name	Time	Method
Sperm motility	Change from baseline sperm motility at 12 weeks	Sperm motility is evaluated by Computer-Aided Semen Analysis, or CASA. Sperm motility will be expressed as '% motile' , the percent of cells that are motile. According to WHO definition, asthenozoospermia is regarded as falling below 40% motility in this study.

Secondary Outcome Measures

Name	Time	Method
Sexual function	Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks	Sexual function was evaluated by Brief Male Sexual Function Inventory (questionnaire) at baseline and 12weeks after intervention
Quality of life	Change from baseline quality of life at 12 weeks	Quality of life was evaluated by The Short Form (36) Health Survey(SF-36 questionnaire) at baseline and 12weeks after intervention
Fatigue questionnaire	Change from baseline Fatigue Severity Scale at 12 weeks	Fatigue was evaluated by Fatigue Severity Scale at baseline and 12weeks after intervention

Trial Locations

Locations (3)

Wonju Severance Christian Hospital; 🇰🇷 Wŏnju, Gangwondo, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Gil Hospital; 🇰🇷 Incheon, Korea, Republic of