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

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 three 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 <30 fertility) 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 three groups after FSH administration. Serum luteinizing hormone and testosterone levels were not significantly increased in any of the groups. Conclusions FSH 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.