Status:
UNKNOWN
Oxidative Stress In Semen And Male Infertility
Lead Sponsor:
Hamad Medical Corporation
Collaborating Sponsors:
Fairhaven Health
Conditions:
Antioxidants
Infertility, Male
Eligibility:
MALE
20-50 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Several studies have been conducted to evaluate the effect of ma...
Eligibility Criteria
Inclusion
- 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
- 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:
- Testosterone \< 10.4 nmol/L
- LH \<1 or \> 9 IU/L and or FSH \<1 or \>19 IU/mL
- Elevated prolactin \>407 mIU/L
- Elevated TSH \> 4.5 U/mL
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03464656
Start Date
January 1 2018
End Date
December 1 2018
Last Update
March 14 2018
Active Locations (1)
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1
Hamad Medical Corporation
Doha, Qatar