Suning Huang, Yudi Song, Ang Cai, Yan Ning
Objective: To evaluate the efficacy and safety of cyclosporine A (CsA)-containing treatment for recurrent spontaneous abortion/recurrent pregnancy loss (RSA/RPL) through a systematic review and meta-analysis. Methods: PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang Database, and VIP were searched from inception to 31 December 2025. Randomized controlled trials and non-randomized controlled studies evaluating CsA-containing treatment in women with RSA/RPL were included. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effects model. The main outcomes were live birth/successful delivery, pregnancy success/fetal protection success, miscarriage using the total enrolled population as the denominator, and maternal adverse events. The certainty of evidence was evaluated using the GRADE approach. Results: 13 studies involving 1181 participants were included. CsA-containing treatment was associated with a higher live birth/successful delivery rate than control treatment (RR = 1.32, 95% CI: 1.21-1.45). It was also associated with a higher pregnancy success/fetal protection success rate (RR = 1.34, 95% CI: 1.22-1.48) and a lower miscarriage rate (RR = 0.42, 95% CI: 0.33-0.54). No statistically significant difference in maternal adverse events was observed between the CsA-containing treatment and control groups (RR = 0.80, 95% CI: 0.43-1.49). The certainty of evidence was rated as low for efficacy outcomes and very low for maternal adverse events. Conclusions: CsA-containing treatment may be associated with improved pregnancy-related outcomes in women with RSA/RPL, including higher live birth/successful delivery and pregnancy success rates and a lower miscarriage rate. However, the certainty of evidence remains limited because of risk of bias, heterogeneous co-interventions, potential publication bias, and insufficient safety reporting. Further high-quality multicenter randomized controlled trials are needed.