Infertility, Male Clinical Trial
Official title:
Oxidative Stress In Semen And Male Infertility
Verified date | January 2018 |
Source | Hamad Medical Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed research aims to study the effects of antioxidant therapy, commonly used in male
infertility treatment, on semen analysis. Patients presenting with male infertility, who are
found to have abnormal semen analysis shall be recruited to this study. They will be asked to
provide a sample of semen for routine semen analysis and advanced semen tests including sperm
DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month
treatment with antioxidants.
After completing the data analysis, we intend to publish the study in high impact perr
reviewed journals and present it in international conferences.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2018 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Abnormal sperm parameters defined as having at least two out of the following three criteria: - Sperm Concentration > 1 and = 15 million per ml - Sperm total Motility = 40% - Sperm Morphology by Strict Criteria; normal forms = 4.0% - Absence of infection in semen (pus cells < 1 X 106/ml) - No history of taking any therapy for their infertility including OTC treatment and vitamin supplementation - No history of obstructive azoospermia - No history of testicular cancer Exclusion Criteria: - Semen volume = 1.5 mL - Hydrocele, clinical varicocele (grade 2 and higher), orchitis, epididymitis, Cryptorchidism, irradiation or subjects that received chemotherapy treatment - Clinically meaningful endocrinopathy defined as an endocrinopathy which requires endocrine medications (e.g. Diabetes, Thyroid disease, Pituitary diseases, Adrenal diseases, etc.) or measurement of the following hormonal values: 1. Testosterone < 10.4 nmol/L 2. LH <1 or > 9 IU/L and or FSH <1 or >19 IU/mL 3. Elevated prolactin >407 mIU/L 4. Elevated TSH > 4.5 U/mL 5. Elevated Estrogen> 275 pmol/L - Leukocytospermia: WBC count of > 1 X 106/ ml - Known HIV infection - Use of antioxidant agents or vitamins within 8 weeks prior to inclusion into the study - Consumption of more than 1 unit of alcohol daily* - Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc. - History of current use of illegal or "recreational" drugs - History of malignancy not curatively treated at least 5 years before screening visit with exception of basal cell carcinoma in situ which may have been curatively treated within 1 year - Participation in another clinical trial within 30 days or 7 half-lives of the prior test product, whichever is longer - Any condition which, in the opinion of the investigator, might put the subject at risk by participation in this study |
Country | Name | City | State |
---|---|---|---|
Qatar | Hamad Medical Corporation | Doha |
Lead Sponsor | Collaborator |
---|---|
Hamad Medical Corporation | Fairhaven Health |
Qatar,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the effect of antioxidant therapy on sperm motility in infertile men, | Measured by mean change in sperm motility pre- and post-treatment with antioxidants. | 1 year | |
Primary | Evaluate the effect of antioxidant therapy on sperm morphology in infertile men | Measured by the mean change in sperm morphology pre- and post-treatment with antioxidants | 1 year | |
Primary | Evaluate the effect of antioxidant therapy on sperm count in infertile men | Measured by mean change in sperm count pre- and post-treatment with antioxidants. | 1 year | |
Secondary | Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men | Difference in mean change in sperm DNA fragmentation pre and post-treatment | 1 year | |
Secondary | Evaluate the effect of antioxidant therapy on oxidative stress in infertile men | Measure difference in mean change in seminal oxidation reduction potential in infertile men pre- and post-treatment. | 1 year |
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