Changes in sperm quality with an antioxidant formula in mild-moderate male infertility: A prospective study

Abstract

Introduction

This study aimed to examine for an association between an antioxidant formula and sperm quality, as well as safety, in males with mild to moderate sub-fertility.

Methods

A prospective, open-label single-arm study examined the association between 24 weeks treatment with a proprietary formula containing 15 vitamins, minerals and antioxidants (including L-carnitine, acetyl-L-carnitine, selenium, folic acid, L-cysteine and Co-enzyme Q10) and sperm quality in healthy males aged 20 – 60 with idiopathic teratospermia, asthenospermia and/or mild-moderate oligospermia. The primary outcome was simultaneous change in sperm concentration, progressive motility and morphology between screening, week 16 and week 24. Secondary outcomes included safety, pregnancy rates, sperm oxidative stress, sperm DNA fragmentation, and serum/plasma nutrient levels.

Results

Sixty-one participants, with a mean age of 35.8 years, were included in the intention-to-treat analysis. No improvement in overall sperm quality was observed (i.e. simultaneous improvement in all three measures) as only two of the three sperm quality measures improved. Mean sperm concentration decreased by 0.24 standard deviations (SD) while mean morphology and motility improved by 0.28 and 0.04 SD respectively, however, these changes did not reach clinical significance (set at ≥ 0.4 SD improvement in means). There were no changes in secondary outcomes apart from an increase in homocysteine and vitamin B12 levels and decrease in high DNA stainability. Fifteen pregnancies were reported (pregnancy rate 29 %). Twenty-one of 62 (33.8 %) participants reported 36 adverse events (AEs), one of which was serious, leading to study withdrawal. Most AEs were of mild intensity and resolved.

Conclusion

Twenty-four weeks of an antioxidant formula was not associated with clinically significant changes in overall sperm quality. The formula was generally safe and well tolerated. Our findings are limited by the single- arm design, and randomised controlled trials are required to confirm or refute our findings.