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 < .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. Conclusion 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.

Coenzyme Q10 and Male Infertility: A Systematic Review

“…A significant increase in sperm concentration was also reported by some authors [13,16,[18][19][20]23], whereas the effects on normal morphology were lower [9,13,18,19,23]. On the other hand, supplementation with compound mixes (including 20-200 mg CoQ10) showed similar effects on sperm density [11,12,24,26,27,29,31,32], motility [10,11,24,25,27,[29][30][31] and morphology [11,[29][30][31][32]. However, the extreme variability of the CoQ10 dosage used in mixed compounds (20-200 mg per day) and the lack of a direct comparison between different nutraceutical preparations makes it difficult to understand how much CoQ10 affects seminal parameters compared to other molecules in mixed compounds.…”

“…Finally, it should be noted that only 5 of 12 studies (42%) with CoQ10 and 2 of 12 studies (12%) with combination treatment had a randomized controlled design, while data on pregnancy rates remain sparse or anecdotal [19,31]. These are important limitations.…”

“…The primary outcome was normalization of semen analysis at 0, 2 and 4 months, whereas the secondary outcome was the pregnancy rate. At 4 months, 69.0% of the patients in the treatment group and 22.0% in the placebo group had normal semen analysis (p < 0.001), whereas the pregnancy rate was significantly higher in the treatment than the placebo group (23.8% and 4.9%, p = 0.017) [31].…”

A Meta-Analysis of the Efficacy of L-Carnitine/L-Acetyl-Carnitine or N-Acetyl-Cysteine in Men With Idiopathic Asthenozoospermia

“…Due to the lack of valid data, 28 studies were excluded. At last, seven RCTs (Ciftci et al, 2009;Jannatifar et al, 2019;Kopets et al, 2020;Lenzi et al, 2004;Micic et al, 2019;Safarinejad & Safarinejad, 2009;Sigman et al, 2006) were used to show the efficacy of LC/LAC and NAC in men with idiopathic asthenozoospermia. Table 1 presents the basic characteristics of each study.…”

Sperm oxidative stress: clinical significance and management

“…Его эффективность доказана не только при идиопатическом бесплодии, но и при наличии явных этиологических факторов, в т.ч. при варикоцеле-ассоциированной субфертильности [46].…”