LAUSR

OBJECTIVE To evaluate the best first line management option for the treatment of unexplained subfertility-controlled ovarian hyperstimulation (COH) with gonadotropins and IUI or IVF. DESIGN Randomized controlled trial. SETTING Single center trial in a tertiary referral unit. PATIENT(S) Couples with unexplained subfertility. INTERVENTION(S) Couples were randomized to receive either three cycles of IUI + COH or one cycle of IVF. MAIN OUTCOME MEASURE(S) Singleton pregnancy rate (PR) per couple. RESULT(S) A total of 207 couples were randomly assigned to three cycles of IUI + COH (n = 101) or one cycle of IVF (n = 106). There were 25 (24.7%) singleton live births for the IUI + COH group and 33 (31.1%) for the IVF group (relative risk, 1.3; 95% confidence interval [CI] 0.81-1.96) with an absolute risk difference of 6.4% (95% CI -5.8% to 18.6%). The multiple pregnancies per live birth were 4 (13.8%) for the IUI + COH group and 3 (8.3%) for the IVF group (relative risk, 0.6; 95% CI 0.14-2.4). There were no cases of ovarian hyperstimulation syndrome (OHSS) in the IUI group and three cases of OHSS (3.7%) in the IVF group. There were 17 live births from spontaneous conception in between treatment cycles (8.2%). CONCLUSION(S) The singleton live birth rate with one cycle of IVF was not significantly different than three cycles of IUI + COH. CLINICAL TRIAL REGISTRATION NUMBER ISRCTN43430382.