Dietary supplementation with a novel L-carnitine multi-micronutrient in idiopathic male subfertility involving oligo-, astheno-, teratozoospermia: a randomized clinical study.

To study the influence of a multicomponent nutrient dietary supplement on sperm parameters and pregnancy rates in idiopathic male infertility (IMI) with oligo-, astheno-, teratozoospermia.A randomized double-blind placebo-controlled prospective parallel arms (1:1 allocation ratio) multi-center clinical trial.Eight urology/reproductive health clinical centers located in Ukraine.Eighty-three males aged 21-50 years with IMI and at least 1 of 3 abnormal values: total sperm concentration < 15 million/ml or/and spermatozoa progressive motility < 32% or/and forms with normal morphology <4%.

Patients were randomly allocated verum test dietary supplement (TDS) containing L-carnitine/acetyl-L-carnitine, L-arginine, glutathione, co-enzyme-Q10, zinc, vitamin B₉ , vitamin B₁₂ , selenium or placebo 1 time daily for 6 months.

The primary outcome measure was the percentage of normal spermiograms (concentration ≥ 15 million/ml and ≥ 32% of spermatozoa with progressive motility and ≥ 4% of normal forms) at month 0, 2 and 4. Percentage of pregnancies served the secondary outcome endpoint. Differences between the groups were assessed in z-test for proportions.All males finished the study. At month 4, 29/42 (69.0%) males in the verum and 9/41 (22.0%) had normal spermiograms (P < 0.001). Percent of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = 0.017). There were no reportable supplement-associated adverse events.Specific multi-nutrient combination L-carnitine/ L-acetyl-carnitine, L-arginine, glutathione, co-enzyme-Q, zinc, folic acid, cyanocobalamin, and selenium can improve sperm quality in males with IMI and increase pregnancy rates.