Infertility, Male Clinical Trial
Official title:
Oxidative Stress In Semen And Male Infertility
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.
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 many antioxidant regimens on male infertility. A randomized double-blind,
placebo-controlled trial investigated a combined antioxidant regimen, including vitamin C,
using Menevit (lycopene 6mg, vitamin E 400IU, vitamin C 100mg, zinc 25mg, selenium 26 mcg,
folate 0.5mg, garlic 1g) in couples undergoing intracytoplasmic sperm injection. The authors
reported a significant improvement in viable pregnancy rate in the treatment group, where
38.5% of transferred embryos resulted in a viable fetus compared to 16% in the placebo group
(Tremellen K, 2007). Suleiman et al. studied 300 mg of daily vitamin E in a
placebo-controlled study revealing significant improvement in sperm motility and reduction of
oxidative stress measures in the treatment group. Moreover, they reported a 21% spontaneous
pregnancy rate in the treatment group compared to 0% in the placebo group (Suleiman SA,
1996).
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. No other
procedures will be done for research purposes. All other investigations or treatments will be
given according to the standard of care. Routinely patients presenting to the male
infertility unit at HMC seeking evaluation and treatment for delayed conception will be
assessed with a history and physical examination, investigated with semen and endocrine
studies and be placed on an antioxidant regimen comprised of vitamins C and E, L-Carnitine
and pentoxyfylline. Further management will be individualized and planned according to each
patient's condition.
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