Effectiveness of recombinant follicle-stimulating hormone treatment in patients with oligo-asthenospermia at different levels of DNA fragmentation index: A phase II clinical trial

Abstract. Objective. This study aimed to perform an evaluation of changes in spermogram parameters after follicle-stimulating hormone (FSH) therapy in infertile males having oligo-asthenospermia at different levels of DNA fragmentation index (DFI). Materials and methods. Infertile men with oligo-asthenospermia, no underlying urogenital disease (such as varicocele), and medically fertile partners were enrolled over 1 year. Semen parameters, FSH, luteinizing hormone, and testosterone levels were determined; also, a Sperm DNA Fragmentation Assay Kit (Hamun Teb Pishro, Tehran, Iran) was used for determining sperm DFI at baseline. Participants were categorized into 3 groups based on DFI: DFI <15% (group 1), DFI of 15%–30% (group 2), and DFI >30% (group 3). All participants received subcutaneous recombinant FSH (150 mg every other day) for 6 months. Sperm specimens were tested 6 months after intervention (a single sperm control test). Results. Sixty males whose average age was 28.4 years were enrolled. Only group 3 (poor fertility) exhibited a significant rise in sperm concentration (p = 0.001) and motility (p < 0.05) after FSH treatment. Group 1 (DFI <15%) and group 2 (DFI of 15%–30%) showed increased mean sperm concentration and motility postintervention, although these alterations were not significantly different. Follicle-stimulating hormone levels increased significantly in all 3 groups after FSH administration. Serum luteinizing hormone and testosterone levels were not significantly increased in any of the groups. Conclusions. Follicle-stimulating hormone treatment improves sperm concentration and motility in men with oligo-asthenospermia, with significant improvements observed in men with DFI >30%. DNA fragmentation index can be a predictive indicator of response to FSH treatment in such patients.