The Effect of Recombinant Human Follicle-Stimulating Hormone on Sperm Quality, Chromatin Status and Clinical Outcomes of Infertile Oligozoospermic Men Candidate for Intracytoplasmic Sperm Injection: A Randomized Clinical Trial

BACKGROUND: Follicle-stimulating hormone (FSH) plays a crucial role in spermatogenesis; in this study, we assessed the effect of recombinant human FSH (rhFSH) on sperm parameters, chromatin status and clinical outcomes of infer- tile oligozoospermic men candidates for intracytoplasmic sperm injection (ICSI). MATERIALS AND METHODS: This interventional randomized clinical trials (IRCT) included 40 infertile oligozoospermic men undergoing ICSI. These individuals were randomized into two groups: 20 men received rhFSH drug for three months and the other 20 men who did not receive rhFSH drug were considered the control group. Before and 3 months after treatment initiation, sperm parameters (using computer-assisted semen analysis) and chromatin status [using chromomycin A3, aniline blue, and sperm chromatin dispersion (SCD) tests] were assessed in these individuals. Fur- thermore, hormonal profile was assessed using enzyme-linked immunosorbent assay (ELISA). Clinical outcomes of ICSI were also compared between the two groups. RESULTS: The rhFSH treated group showed a significant increase in the level of FSH, luteinizing hormone (LH), tes- tosterone (T) and prolactin (PRL), as well as significant improvements in sperm parameters compared to the control group. Also, after administration of rhFSH, there was asignificant reduction in the percentage of sperm DNA damage, protamine deficiency and chromatin immaturity, while such a reduction in these parameters was not observed in the control group. Moreover, the percentage of embryos with grade Aquality, was significantly higher in the rhFSH group compared to the control group. The pregnancy rate in the rhFSH group was higher than the control group but the dif- ference was insignificant. CONCLUSION: Administration of rhFSH improves sperm quality in infertile oligozoospermic men and results in higher rates of good quality embryos post-ICSI (Registration number: IRCT20170923036334N2).