An open-label, multi-center, prospective, interventional, clinical study to evaluate the efficacy and safety of Ayuvigo forte capsules in patients suffering from oligospermia

Background: Oligospermia refers to semen with a low concentration of sperms. Oligospermia is one of the common causative factors of male infertility. Objectives: The objective of this study was to assess the efficacy and safety of Ayuvigo forte capsule in patients suffering from oligospermia. Materials and Methods: This was an open-label, prospective, interventional, multi-center clinical study. A total of 30 patients were completed the study. All patients were advised to consume two Ayuvigo forte capsules twice daily orally after meals with a cup of milk for 90 days. Data describing quantitative measures are expressed as a mean ± standard deviation. Results: The mean total sperm count, mean progressive sperm motility, and total number of spermatozoa increased significantly (P < 0.05) by 90.54%, 33.65%, and 98.88% at the end of the study, respectively. Most patients had shown significant (P < 0.05) improvement in subjective parameters of low sperm count assessed as per Ayurveda. Furthermore, significant (P < 0.05) improvement was observed in mean serum free testosterone level. No statistically significant (P > 0.05) changes were observed in mean serum luteinizing hormone, follicle-stimulating hormone, prolactin, safety laboratory parameters, and vitals. Excellent overall efficacy and tolerability were observed in majority of patients. Conclusion: Ayuvigo forte capsule is safe and effective for the management of oligospermia.