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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low group | Experimental | GINST15 3g/day |
|
| High group | Experimental | GINST15 6g/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GINST | Dietary Supplement | The study is designed with using GINST either 500mg/capsule or 1000mg/capsule, two capsules at once, three times a day for 12 weeks. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Recruiting | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Assessment of quality of life by questionaire (SF-36, Brief sexual function inventory, fatigue severity scale) |
| 12 week |