Testicular regulatory peptides as an advanced method of treatment of male infertility in outpatient settings: outcomes

Background: inability to conceive (infertility) affects both men and women. Most cases are idiopathic, and clinicians lack the tools for precise diagnosis and therapy. In this regard, development and study of new effective safe methods of conservative treatment of male infertility are of great interest Aim: to compare efficiency between testicular regulatory peptide (TRP)-based parenteral biologically active supplements (BAS) and combined therapy (TRP-based BAS + parenteral antioxidants) in men with oligoastenotheratozoospermia associated with double-stranded DNA break. Patients and Methods: a prospective study (n=65) was conducted from February, 2023 to July, 2024. A Group I (n=35) received TRP-based BAS, and a Group II (n=30) used combined therapy (BAS + antioxidants). The ejaculate was examined at the baseline, in 100 days after the start of the therapy, and in 60 days after the Visit 2. DNA fragmentation index (DFI) dynamics, sperm concentration (K) and motility (PR), as well as pregnancy rate were efficiency criteria Results: in the Group I, DFI was 18% on average and 14.1% at the baseline and at the end of the follow-up period, respectively. As for other indicators, K was 6.9±0.17 vs. 14.6±1.3 million/ml, and PR was 17.34±1.12% vs. 32.5±0.98%, respectively. Live births were reported in 17 (48.5%) married couples both by means of assisted reproductive technologies (ART) (n=4) and a natural cycle (n=13). In the Group II, DFI was 21% on average and 13.3% at the baseline and at the end of the follow-up period, respectively. Other indicators demonstrated a following trend: K — 7.1±0.2 million/ml vs. 20.6±0.43 million/ml, and PR — 13.25±0.22% vs. 37±0.31%, respectively. Live births were achieved by 16 (53.3%) married couples both by means of ARTs (n=3) and a natural cycle (n=13). Conclusion: TRP-based therapy in men with severe infertility (oligoasthenoteratozoospermia) and high DFI promotes pregnancy and live birth Adjunctive parenteral antioxidant therapy is likely to reduce a risk of non-developing pregnancy in a couple with a high DFI KEYWORDS: male infertility factor, spermatogenesis, sperm DNA fragmentation index, regulatory peptides, assisted reproductive technologies, pregnancy. FOR CITATION: Gevorkyan A.R. Testicular regulatory peptides as an advanced method of treatment of male infertility in outpatient settings: outcomes. Russian Medical Inquiry. 2025;9(4):229–234 (in Russ.). DOI: 10.32364/2587-6821-2025-9-4-7