Treatment of couples with unexplained subfertility and an unfavourable prognosis. A randomised trial comparing the effectiveness of IUI with ovarian hyperstimulation and IVF with single embryo transfer.

Couples with unexplained or mild male subfertility and a small chance of spontaneous pregnancy (<30%, calculated by the validated model of Hunault (Hunault et al., 2005, Van der Steeg et al., Submitted)), are currently treated with Intrauterine Insemination (IUI) and Controlled Ovarian Hyperstimulation (COH). This treatment results in 10-20% multiple pregnancies. Multiple pregnancies more often result in obstetrical and neonatal complications- e.g. premature birth, growth retardation and preeclampsia. These complicated pregnancies result in higher medical costs. Usually these subfertile patients are treated with IUI-COH followed by In Vitro Fertilization (IVF) with Double Embryo Transfer (DET). However an alternative strategy to prevent multiples would be IVF with Single Embryo Transfer (SET), and cryopreservation of spare embryos.
Our hypothesis is that one cycle of IVF-SET followed by embryo-transfers of cryo-preserved embryos is comparable to three cycles of IUI-COH concerning ongoing pregnancy and costs of these treatments. Multiple pregnancies however are largely prevented.
Our aim is to test our hypothesis in 100 subfertile couples which would in our setting normally have been treated with IUI-COH. The primary outcome measure in both groups is ongoing pregnancy. Secondary outcomes are multiple pregnancies, clinical pregnancies, life birth and complications during pregnancy.

One cycle of IVF-eSET followed by transfer of frozen embryos is at least as effective as three cycles of IUI-COH in terms of ongoing pregnancy. Multiple pregnancies however can largely be prevented by treating women with IVF-eSET.

Comparison of IVF in a long protocol with elective Single Embryo Transfer, and IUI-COH, in couples with unexplained or mild male subfertility and poor fertility prospects.