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

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.