Abstract
OBJECTIVE: To explore the therapeutic efficacy of intrauterine perfusion of cyclosporin A (CsA) in intractable recurrent spontaneous abortion (RSA) patients with endometrial alloimmune dysfunction. METHODS: This is a randomized controlled trial (RCT) of patients with intractable RSA with endometrial alloimmune disorders. A total of 201 women were enrolled, all of whom had at least 3 serial abortions and endometrial alloimmune dysfunction. Participants were randomly assigned to two groups. The CsA group (n = 101) received intrauterine infusion of 250 mg CsA on the 3rd and 7th days after menstruation for 2 menstrual cycles, while the placebo group (n = 100) received placebo. The birth of healthy, deformity-free babies was the main study outcome. RESULTS: In total, 75 (74.26%) women in the CsA group and 59 (59.00%) women in the placebo group gave birth to healthy babies [P = 0.01, OR = 2.01; 95% CI (1.10∼3.65)]. Compared to the placebo group, the CsA group had dramatically lower endometrial CD56(+) cell and CD57(+) cell concentrations at the luteal phase of the second menstrual cycle (P < 0.05). CONCLUSION: Intrauterine perfusion of CsA was confirmed to be a promising approach for the treatment of intractable alloimmune RSA.