Effects of GINST on Human Semen
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GINST
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility
Eligibility Criteria
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
Sites / Locations
- Severance hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low group
High group
Arm Description
GINST15 3g/day
GINST15 6g/day
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
serum hormones (serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone)
serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone
Quality of Life (SF-36, Brief sexual function inventory, fatigue severity scale)
Assessment of quality of life by questionaire (SF-36, Brief sexual function inventory, fatigue severity scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02285335
Brief Title
Effects of GINST on Human Semen
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low group
Arm Type
Experimental
Arm Description
GINST15 3g/day
Arm Title
High group
Arm Type
Experimental
Arm Description
GINST15 6g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
GINST
Intervention Description
The study is designed with using GINST either 500mg/capsule or 1000mg/capsule, two capsules at once, three times a day for 12 weeks.
Primary Outcome Measure Information:
Title
Semen quality (assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis)
Description
Semen quality assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis
Time Frame
12 week
Secondary Outcome Measure Information:
Title
serum hormones (serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone)
Description
serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone
Time Frame
12 week
Title
Quality of Life (SF-36, Brief sexual function inventory, fatigue severity scale)
Description
Assessment of quality of life by questionaire (SF-36, Brief sexual function inventory, fatigue severity scale)
Time Frame
12 week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Sik Choi, MD
Phone
82-2-2228-2230
Email
yschoi08@yuhs.ac
12. IPD Sharing Statement
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Effects of GINST on Human Semen
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