Safety and efficacy of autologous bone marrow aspirate concentrate injection for idiopathic male infertility: A comparative study.

BACKGROUND

Although limited clinical evidence exists, such as case reports of azoospermia treatment in humans using bone marrow aspirate concentrate (BMAC) injection, these findings provide a compelling foundation for exploring mesenchymal stem cell therapy in male infertility.

AIM: To evaluate the safety and efficacy of autologous BMAC injection into human testis for men with severe oligospermia or azoospermia over the existing standard of care pharmacotherapy and lifestyle modifications.

METHODS

We included patients diagnosed with male infertility of the age group between 35-45 years in this trial comparing BMAC injection therapy with pharmacotherapy and lifestyle modifications over a 6-month follow-up period. Semen analysis was used to evaluate the efficacy of the interventions analyzed.

RESULTS

We enrolled 30 patients in the trial with 10 patients in each arm of the trial. Compared to the baseline, neither the BMAC group (P = 0.139) or pharmacotherapy group (P = 0.056) nor the lifestyle modification group (P = 0.112) demonstrated a statistically significant increase in sperm count at 6 months. However, the BMAC group demonstrated a significant increase in sperm count (mean 19.2 million; P = 0.001) compared to the pharmacotherapy group (mean 3.5 million) and lifestyle modification group (mean 2.2 million) at 6 months. Significant improvement was noted in the motility grade (P < 0.001) only in the BMAC group while no changes were noted in the other groups.

CONCLUSION

This trial highlights the potential of autologous BMAC as a promising therapeutic option for male infertility. Despite the absence of significant changes within individual treatment arms, BMAC therapy demonstrated superior efficacy in improving both sperm count and motility compared to standard pharmacotherapy and lifestyle modifications. These findings underscore the potential role of regenerative medicine in addressing severe oligospermia and azoospermia, warranting further research to solidify its clinical applicability.