Double‐blind, randomised, placebo‐controlled trial on the effect of L‐carnitine and L‐acetylcarnitine on sperm parameters in men with idiopathic oligo

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Double‐blind, randomised, placebo‐controlled trial on the effect of L‐carnitine and L‐acetylcarnitine on sperm parameters in men with idiopathic oligoasthenozoospermia

Sava Micic | Natasa Lalic | Dejan Djordjevic | Nebojsa Bojanic | Natasa Bogavac‐ Stanojevic | Gian Maria Busetto | Ashraf Virmani | Ashok Agarwal





Abstract

Carnitine is essential for energy metabolism and spermatozoa maturation. Combining L‐carnitine and L‐acetylcarnitine with micronutrients has been investigated as a treatment for infertility in men. We evaluated the effects of a therapeutic formulation, Proxeed Plus, on sperm parameters in oligoasthenozoospermic men. This pro‐ spective, randomised, double‐blind, placebo‐controlled clinical trial involved 175 males (19–44 years) with idiopathic oligoasthenozoospermia who failed to impregnate their partners (12 months). Males received Proxeed Plus or placebo for 3 and 6 months. Sperm volume, progressive motility and vitality significantly (p < 0.001) improved after 6 months compared to baseline. Sperm DNA fragmentation index significantly decreased compared to baseline (p < 0.001) and the 3‐month therapy (p = 0.014) in treated men. Increased seminal carnitine and α‐glucosidase concentration also positively correlated with improved progressive motility. Decreased DNA fragmentation index was the good predictor of progressive sperm motility >10%, and simultaneous measurement of changes in sperm vitality and DNA fragmentation index gave the highest probability of sperm motility 10% (AUC = 0.924; 95% CI = 0.852–0.996; p < 0.001). Logistic regression analyses revealed DNA fragmentation index decrease as the only independent predictor of sperm motility 10% (OR = 1.106; p = 0.034). We have demonstrated the beneficial effects of carnitine derivatives on progressive motility, vitality and sperm DNA fragmentation. Combining metabolic and micronutritive factors is beneficial for male infertility.




In this study, after 6 months of therapy with the formulation of LC and ALC, we observed significant beneficial effects in progressive motility, vitality and DNA fragmentation. These results suggest that seminal levels of LC play an essential role in maintaining male fertility. Moreover, these results support the significance of formulations that combine metabolic and nutritive factors as a therapy to treat male infertility and recover the functional capacity of spermatozoa.
 

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The applied test formulation consisted of 1,000 g LC, 0.5 g ALC, 0.725 g fumarate, l g fructose, 50 mg citric acid, 10 mg zinc, 20 mg coenzyme Q10, 50 µg selenium, 90 mg vitamin C, 200 µg folic acid and 1.5 µg vitamin B12. The placebo was made with the excipients (sucrose, silica [anti‐caking], lemon flavour, acesulfame K [E950, sweetener]) of the supplementation without the active substances.
 
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