Background: The role of hormonal therapy as an adjunct to surgery in managing undescended testes (UDT) remains controversial. Its implications for future fertility are still unclear, and clinical practices vary globally.
Objective: To evaluate the effects of combined hormonal and surgical treatment versus surgery alone on fertility potential in males with UDT.
Study design: A systematic review and meta-analysis were conducted following PRISMA 2020 guidelines. Databases searched included PubMed, Scopus, Embase, ClinicalTrials.gov, and Cochrane up to April 14, 2025. Eligible studies were randomized controlled trials and cohort studies comparing combined hormonal and surgical therapy with surgery alone, reporting on fertility-related potentials. Risk of bias was assessed using RoB 2.0 or the Newcastle-Ottawa Scale, and data synthesis was performed using RevMan 5.4.
Results: Nine studies comprising 652 patients were included. Hormonal therapy combined with surgery significantly increased the number of spermatogonia per tubule (mean difference [MD] 0.23; 95 % CI: 0.07 to 0.38; p = 0.003), with more pronounced effects in bilateral UDT (MD 0.35; 95 % CI: 0.17-0.53; p = 0.001). However, no significant improvements were observed in long-term fertility markers, including sperm count, inhibin B, or testosterone. FSH levels were slightly lower in the combined group (MD -0.77 IU/L; 95 % CI: -1.29 to -0.26; p = 0.003).
Conclusion: Adjunctive hormonal therapy may enhance early germ cell maturation, particularly in bilateral UDT. However, current evidence does not demonstrate clear long-term benefits in fertility-related potentials. Future high-quality, biomarker-stratified, and longitudinal studies are essential, and should include direct endpoints such as sperm counts and paternity, to fully determine the clinical utility of pre-orchidopexy hormonal treatment.
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