- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02285335
Effects of GINST on Human Semen
March 25, 2019 updated by: Yonsei University
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 120-752
- Recruiting
- Severance Hospital
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Contact:
- Young Sik Choi, MD
- Phone Number: 82-2-2228-2230
- Email: yschoi08@yuhs.ac
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low group
GINST15 3g/day
|
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
|
The study is designed with using GINST either 500mg/capsule or 1000mg/capsule, two capsules at once, three times a day for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum hormones (serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone)
Time Frame: 12 week
|
serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone
|
12 week
|
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)
|
12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Anticipated)
August 1, 2019
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
November 3, 2014
First Submitted That Met QC Criteria
November 6, 2014
First Posted (Estimate)
November 7, 2014
Study Record Updates
Last Update Posted (Actual)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2014-0708
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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