Effects of GINST on Human Semen

Yonsei University

Status: Unknown

Conditions: Infertility

Treatments: Dietary Supplement: GINST

Study type: Interventional

Funder types: Other

Identifiers

NCT02285335

4-2014-0708

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Low group

Experimental group

Description:

GINST15 3g/day

Treatment:

Dietary Supplement: GINST

High group

Experimental group

Description:

GINST15 6g/day

Treatment:

Dietary Supplement: GINST