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Effects of GINST on Human Semen

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Yonsei University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285335
First Posted: November 7, 2014
Last Update Posted: November 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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.

Condition Intervention
Infertility Dietary Supplement: GINST

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Semen quality (assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis) [ Time Frame: 12 week ]
    Semen quality assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis


Secondary Outcome Measures:
  • serum hormones (serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone) [ Time Frame: 12 week ]
    serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone

  • Quality of Life (SF-36, Brief sexual function inventory, fatigue severity scale) [ Time Frame: 12 week ]
    Assessment of quality of life by questionaire (SF-36, Brief sexual function inventory, fatigue severity scale)


Estimated Enrollment: 60
Study Start Date: November 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low group
GINST15 3g/day
Dietary Supplement: GINST
The study is designed with using GINST either 500mg/capsule or 1000mg/capsule, two capsules at once, three times a day for 12 weeks.
Experimental: High group
GINST15 6g/day
Dietary Supplement: GINST
The study is designed with using GINST either 500mg/capsule or 1000mg/capsule, two capsules at once, three times a day for 12 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285335


Locations
Korea, Republic of
Severance hospital Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Young Sik Choi, MD    82-2-2228-2230    yschoi08@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02285335     History of Changes
Other Study ID Numbers: 4-2014-0708
First Submitted: November 3, 2014
First Posted: November 7, 2014
Last Update Posted: November 7, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female