Intrauterine insemination with gonadotropin stimulation or in vitro fertilization for the treatment of unexplained subfertility: a randomized controlled trial.

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.