Oxidative Stress In Semen And Male Infertility

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03464656
• Date of registration: 26/02/2018
• Prospective Registration: No
• Primary sponsor: Hamad Medical Corporation
• Public title: Oxidative Stress In Semen And Male Infertility
• Scientific title: Oxidative Stress In Semen And Male Infertility
• Date of first enrolment: January 1, 2018
• Target sample size: 100
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03464656
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Qatar

Contacts

• Name: Mohamed Arafa, MD

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Antioxidants

Infertility, Male

Semen Quality

Intervention(s)

Diagnostic Test: Semen analysis

Diagnostic Test: Sperm DNA fragmentation

Drug: Fairhaven Pro for men

Diagnostic Test: Static Oxidation reduction potential in semen

Primary Outcome(s)

Evaluate the effect of antioxidant therapy on sperm count in infertile men [Time Frame: 1 year]

Evaluate the effect of antioxidant therapy on sperm morphology in infertile men [Time Frame: 1 year]

Evaluate the effect of antioxidant therapy on sperm motility in infertile men, [Time Frame: 1 year]

Secondary Outcome(s)

Evaluate the effect of antioxidant therapy on oxidative stress in infertile men [Time Frame: 1 year]

Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men [Time Frame: 1 year]

Secondary ID(s)

16351/16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fairhaven Health