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

Abstract

Objective: 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. Design: A randomized, double-blind, placebo-controlled, prospective, parallel arms (1:1 allocation ratio), multi-center clinical trial. Settings: Eight urology/reproductive health clinical centers located in Ukraine. Patients: 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%. Intervention(s): 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. Main Outcome(s): 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. Results: 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