Oxidative Stress In Semen And Male Infertility

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Collaborator: Fairhaven Health
• Treatments: Antioxidants

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