Effects of GINST on Human Semen

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect of GINST on human semen. The study is a pilot study, designed as open-label, prospective randomized clinical trial using GINST either 500mg/capsule (panax ginseng 0.96g/day) or 1000mg/capsule (panax ginseng 1.92g/day), two capsules at once, three times a day for 12 weeks. GINST(Ilhwa, Republic of Korea) is a dietary supplement capsule, which is made with 6 year-old Korean red ginseng (Panax ginseng). Expected participants are to be male partners of female patients who visit infertility clinic at Severance hospital, whose total motile sperm count is more than 0.5x106 by semen analysis using computer aided sperm analyzer (CASA). Semen analysis, blood test, questionaires are planned to be performed 2 times, on the initial visit and after 12weeks of GINST treatment. Semen analysis will reveal ejaculated volume, sperm count, motility, morphology, total leukocyte count, total motile sperm count, further analysis including sperm chromatin assessment to examine the quality of sperm and malondialdehyde (MDA) analysis of seminal fluid to assess oxidative stress will be performed. Blood test will be done including serum follicle stimulating hormone (FSH), luteinizing hormone (LH), total and free testosterone. Quality of life, sexual performance before and after taking GINST will be evaluated using questionaires.

Conditions
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Infertility

Intervention / Treatment
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* Dietary Supplement: GINST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: partner of female patient who visit infertility clinic with chief complaint of infertility. ≥0.5x106 of total motile sperm count on screening semen analysis. Exclusion Criteria: Those who have chronic, systemic disease or endocrinologic disorder. Patients with hypertension (systolic blood pressure ≥ 140mmHg, diastolic blood pressure ≥ 90mmHg) Patients who have undergone chemotherapy due to malignancy Patient who has history of taking testosterone or anti androgen agents within 1 month. Patient who has retrieved sperm surgically

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low group<br>GINST15 3g/day | Dietary Supplement: GINST<br>* The study is designed with using GINST either 500mg/capsule or 1000mg/capsule, two capsules at once, three times a day for 12 weeks.<br>|
| Experimental: High group<br>GINST15 6g/day | Dietary Supplement: GINST<br>* The study is designed with using GINST either 500mg/capsule or 1000mg/capsule, two capsules at once, three times a day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen quality (assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis) | Semen quality assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum hormones (serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone) | serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone | 12 week | 
| Quality of Life (SF-36, Brief sexual function inventory, fatigue severity scale) | Assessment of quality of life by questionaire (SF-36, Brief sexual function inventory, fatigue severity scale) | 12 week |