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

Abstract

To study the influence of a multi-component nutrient dietary supplement on sperm parameters and pregnancy rates in idiopathic male infertility (IMI) with oligo-, astheno-, and 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 21-50years 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 6months. 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. The 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<.001). The percentage 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=.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.