(067) EFFECTS OF ORAL TESTOSTERONE UNDECANOATE ON SEMEN PARAMETERS IN HYPOGONADAL MEN: AN INTERIM ANALYSIS OF A PROSPECTIVE PILOT STUDY

Abstract Introduction Testosterone replacement therapy (TRT) is commonly prescribed for men with hypogonadism. While injectable testosterone preparations are widely used, oral testosterone formulations have become an increasingly popular treatment option due to their ease of administration and avoidance of repeated intramuscular injections. However, the effects of oral testosterone on semen analysis (SA) parameters and male fertility potential remain understudied. Objective To evaluate changes in semen analysis parameters, including sperm concentration, motility, and morphology, among hypogonadal men receiving oral testosterone undecanoate therapy. Methods A pilot prospective study was conducted enrolling hypogonadal men. Exclusion criteria included prior TRT, use of clomiphene citrate or human chorionic gonadotropin, and azoospermia. Participants received oral testosterone undecanoate for 3 months. SA evaluating sperm concentration, motility, and volume were performed at baseline and 3 months. Concurrent biochemical assessment included measurement of reproductive hormone levels and hematocrit. An interim blood draw was made for drug titration to the therapeutic testosterone range. Baseline and follow-up semen parameters and hormonal values were compared using paired statistical tests. The primary outcome was a change in semen parameters after 3 months of oral testosterone therapy. Results At the interim analysis with 5 patients enrolled thus far, the mean age was 39.6 years (SD: 5.36). Overall, only one patient became azoospermic. When excluding him, a statistically significant increase in total testosterone levels was observed between baseline and follow-up (220.60 ± 42.54 ng/dL vs. 704.67 ± 188.83 ng/dL, p = 0.02), as well as for free testosterone (62.64 ± 9.78 ng/dL vs. 221.98 ± 43.78 ng/dL, p = 0.01). No significant differences were detected between baseline and follow-up values for estradiol, follicle-stimulating hormone, luteinizing hormone, or hematocrit levels. Semen analysis parameters, including sperm concentration, motility, and volume, did not demonstrate statistically significant changes from baseline to 3-month follow-up. These preliminary findings are summarized in Table 1. Conclusions In this pilot study expected increases in total and free testosterone levels were achieved, confirming adequate treatment. No significant changes in semen parameters or other reproductive hormones were observed after 3 months of treatment. Larger scale studies are needed to fully evaluate the effects of oral testosterone formulations on semen quality and male fertility potential. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Disclosures: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast, Halozyme Investor: Sprout.