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Open-label randomized comparative clinical study of the efficacy and safety of the multicomponent complex in the treatment of male infertility

Urologiia. 2026 Jul;(3):71-76.

ABSTRACT

AIM: To evaluate the efficacy and safety of the multicomponent complex in the treatment of male infertility.

MATERIALS AND METHODS: A total of 90 patients aged 18-45 years with a confirmed diagnosis of male infertility, defined as oligozoospermia and/or asthenozoospermia were included in the study. After application of the exclusion criteria, the patients were divided into three groups. Patients in group 1 received standard lifestyle modification recommendations and the complex dietary supplement, 1 sachet once daily for 3 months; patients in group 2 received 2 sachets daily; and patients in group 3 received standard lifestyle modification recommendations only. Semen analysis was performed before enrolment and on days 30, 60, and 90. Statistical analysis was performed using IBM SPSS Statistics version 26.0.00.

RESULTS: After 90 days of therapy, significant differences between the study groups were identified in sperm motility parameters and reactive oxygen species (ROS) generation. Significant between-group differences were observed in the proportion of progressively motile spermatozoa (p=0.0037), total sperm motility (p=0.002), total progressively motile sperm count (p=0.029), total motile sperm count (p=0.0165), and ROS levels (p=0.0086). Ejaculate volume, sperm concentration, total sperm count, sperm morphology, DNA fragmentation index, and HBA test results did not differ significantly between the groups (p>0.05). Post hoc analysis showed significant differences in the proportion of motile and progressively motile spermatozoa, as well as in ROS levels, between groups 1 and 3 and between groups 2 and 3; no significant differences were observed between groups 1 and 2.

CONCLUSION: The use of the complex dietary supplement was associated with improved sperm motility parameters and reduced oxidative stress as early as during the first 1-2 months of administration, with the effect persisting through day 90.

PMID:42687540