Effects of GINST on Human Semen

Not Applicable

• Conditions: Infertility
• Interventions: Dietary Supplement: GINST

• Registration Number: NCT02285335
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

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

Inclusion Criteria

1. partner of female patient who visit infertility clinic with chief complaint of infertility.
2. ≥0.5x106 of total motile sperm count on screening semen analysis.

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Exclusion Criteria

1. Those who have chronic, systemic disease or endocrinologic disorder.
2. Patients with hypertension (systolic blood pressure ≥ 140mmHg, diastolic blood pressure ≥ 90mmHg)
3. Patients who have undergone chemotherapy due to malignancy
4. Patient who has history of taking testosterone or anti androgen agents within 1 month.
5. Patient who has retrieved sperm surgically

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High group	GINST	GINST15 6g/day
Low group	GINST	GINST15 3g/day

Primary Outcome Measures

Name	Time	Method
Semen quality (assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis)	12 week	Semen quality assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of