[Intra-uterine insemination with controlled ovarian hyperstimulation compared to an expectant management in couples with unexplained subfertility and an intermediate prognosis: a randomised study]

Abstract

Objective: Intrauterine insemination (IUI) with controlled ovarian hyperstimulation (COH) is commonly used as treatment of first choice in couples with unexplained subfertility. This treatment should only be applied when there is a realistic increase in chance of pregnancy, particularly because it carries the increased risk of multiple pregnancies. We evaluated the effectiveness of IUI with COH relative to expectant management in couples with unexplained subfertility and an intermediate prognosis of a spontaneous ongoing pregnancy.

Design: Multicentre randomised clinical study.

Method: 253 couples with unexplained subfertility and a probability of a spontaneous ongoing pregnancy of 30% to 40% within 12 months, were randomly assigned to IUI with COH for 6 months or expectant management for 6 months. The primary endpoint of our study was ongoing pregnancy within 6 months. Analysis was carried out according to the intention to treat principle. This study was registered with the Dutch Trial Register and has the International Standard Randomised Clinical Trial number ISRCTN72675518.

Results: Of the 253 couples included, 127 couples were allocated to IUI with COH and 126 to expectant management. In the intervention group, 42 women (33%) conceived, of which 29 pregnancies were ongoing (23%). In the expectant management group, 40 women (32%) conceived, of which 34 pregnancies were ongoing (27%) (relative risk: 0.85; 95% CI: 0.63-1.1). In the expectant management group one twin pregnancy occurred and in the intervention group one woman conceived twins and one a triplet.

Conclusion: A substantial beneficial effect of IUI with COH in couples with unexplained subfertility and an intermediate prognosis can be excluded. Expectant management for a period of 6 months therefore appears justified in these couples.