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.
Andrology. 2020 Apr 24 [Epub ahead of print]
Roman Kopets, Ivan Kuibida, Iryna Chernyavska, Vasyl Cherepanyn, Roman Mazo, Vitaliy Fedevych, Sergiy Gerasymov
Medical Center "Astar", 10/4 Technichna str, Lviv, 79000, Ukraine., Precarpathian Center of Reproductive Health, 49 Chornovola str, Ivano-Frankivsk, 76000, Ukraine., Mykolaiv State Clinical Hospital, 1 Kyivska str, Mykolaiv, 54058, Ukraine., Lviv State Center for the Reproductive Health, 9 Korolenka str, Lviv, 79008, Ukraine., Private Urologic Practice, 169 Bohoiavlenskyi str 32/51, Mykolaiv, 54052, Ukraine., Lviv State Hospital, 7 Nekrasova str, Lviv, 79010, Ukraine., MedianaStatistics, 15-A Skrypnyka str, Lviv, 79012, Ukraine.