Low-dose aspirin therapy and hypertensive pregnancy complications in unselected IVF and ICSI patients: A randomized, placebo-controlled, double-blind study

Low-dose aspirin therapy could improve remodelling of maternal spiral arteries during early placentation and prevent subsequent pregnancy-related hypertensive disorders. We investigated whether low-dose aspirin therapy reduces the incidence of hypertensive pregnancy complications in unselected IVF and ICSI patients when medication was started prior to pregnancy. Methods A total of 487 patients who underwent IVF/ICSI were randomized to receive 100 mg aspirin (n = 242) or placebo (n = 245) daily, starting on the first day of gonadotrophin stimulation. Pregnant women continued the medication until delivery. A total of 107 patients (52 with aspirin and 55 with placebo) experienced live birth and were included in this follow-up study. The main outcome measure was the incidence of hypertensive pregnancy complications. Results Embryo transfer took place in 227 (94) women in the aspirin group and in 229 (93) women in the placebo group. The live birth rate between the aspirin (22.9) and placebo (24.0) groups did not differ significantly (P = 0.78). The overall incidence of hypertensive pregnancy complications was 15.4 (8/52) in the aspirin group and 18.2 (10/55) in the placebo group (P = 0.70, 95 confidence interval for the difference of proportions -17 to 11). There were two cases of severe pre-eclampsia in the aspirin group and three cases in the placebo group. Conclusions In the present study, the incidence of hypertensive pregnancy complications did not differ statistically significantly between low-dose aspirin and placebo groups in unselected IVF/ICSI patients, when medication was started concomitantly with gonadotrophin stimulation and continued until delivery.