Marek Broul, Michal Dubský, Aneta Hujová, Michaela Liegertová
Human evidence is concentrated around glucagon-like peptide-1 receptor agonists (GLP-1 RAs), dual GLP-1/GIP receptor agonism, SGLT2 inhibitors, and metformin or paternal exposure. Direct fertility and live-birth data remain sparse. Trial registries include more male reproductive endpoints than published studies report. Regulatory labels mainly inform genital-safety counseling and nonclinical reproductive toxicology language. Patents contain erectile and male reproductive claims, but these claims are not clinical evidence.
BACKGROUND: Drugs used for diabetes and obesity increasingly shape male sexual and reproductive counseling, but clinical studies, trial registrations, regulatory labels, and patents answer different questions.
OBJECTIVES: The objective is to map these sources and define what each can support when counseling men receiving metabolic drugs.
MATERIALS AND METHODS: We reviewed human studies, ClinicalTrials.gov records, FDA/EMA labels, and selected patent or pipeline documents using source-specific eligibility criteria and evidence rules.
RESULTS: Human evidence is concentrated around glucagon-like peptide-1 receptor agonists (GLP-1 RAs), dual GLP-1/GIP receptor agonism, SGLT2 inhibitors, and metformin or paternal exposure. Direct fertility and live-birth data remain sparse. Trial registries include more male reproductive endpoints than published studies report. Regulatory labels mainly inform genital-safety counseling and nonclinical reproductive toxicology language. Patents contain erectile and male reproductive claims, but these claims are not clinical evidence.
DISCUSSION AND CONCLUSION: Counseling should separate genital safety, endocrine and sexual-function signals, semen and fertility outcomes, and paternal-exposure concerns. Hormonal, sexual-function, or semen changes may track metabolic recovery; they do not establish improved conception or live birth. These drugs should be selected for metabolic indications, not as treatments for ED or infertility.