Received October 28, 2025
Accepted November 09, 2025

Reproductive failure, including recurrent pregnancy loss (RPL) and recurrent implantation failure (RIF), is frequently associated with immune dysregulation at the maternal–fetal interface. Recombinant human granulocyte colony-stimulating factor (rhG-CSF) has been proposed as an immunomodulatory therapy to improve reproductive outcomes. This systematic review and meta-analysis included ten randomized controlled trials evaluating the effects of rhG-CSF in women with RPL or RIF. The primary outcomes were clinical pregnancy rate (CPR), live birth rate (LBR), and miscarriage rate (MR). No overall benefit of rhG-CSF on CPR was observed (OR = 1.16; 95% CI: 0.48–2.80; p = 0.74), with high heterogeneity (I² = 86%). Subgroup analysis revealed that rhG-CSF significantly improved CPR in RIF patients (OR = 1.73; 95% CI: 1.17–2.55; p = 0.006; I² = 17%) but showed no significant effect in RPL. No statistically significant differences were observed for LBR (OR = 1.53; 95% CI: 0.88–2.66; p = 0.13) or MR (OR = 0.72; 95% CI: 0.26–1.96; p = 0.52) in the overall population. Safety data, as well as obstetric and perinatal outcomes, were poorly reported across studies. The high heterogeneity across studies likely reflects differences in patient selection, rhG-CSF administration protocols, and the absence of immunological criteria for identifying responsive subgroups. While rhG-CSF appears to benefit patients with RIF, particularly regarding implantation, its role in improving live birth remains uncertain. Future randomized controlled trials should focus on standardized treatment protocols and incorporate immunogenetic diagnostics to optimize patient selection and clinical outcomes.