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.

Keywords

Male infertility / Oligo-asthenospermia / Follicle-stimulating hormone / Sperm DNA fragmentation / Semen analysis

Acknowledgments

The authors would like to thank the “Clinical Research Development Unit” of Imam-Reza and Qaem hospitals for their valuable contributions to the project.

Statement of ethics

The ethics committee of Mashhad University of Medical Sciences endorsed this study (with the ethics code of MUMS.MEDICAL.REC.1398.175). Enrolled cases signed consent forms. All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards (IRCT registration number, IRCT20101130005280N28).

Conflict of interest statement

The authors declare no conflicts of interest.

Funding source

The study was funded by a research grant from Mashhad University of Medical Sciences (grant number 971700).

Author contributions

SS, AA: Research design, project development;

SS: Editing;

NT: Writing, editing;

ME: Data collection;

AA, SE: Data analysis;

SMS: Data collection.

Data availability

The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.

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