METHODS Five hundred and eighty women across five Scottish hospitals were randomized to either EM, CC or IUI for 6 months. The primary outcome measure was live births. Resource-use data were collected during the trial and costs were calculated from a UK National Health Service (NHS) perspective. Incremental cost–effectiveness ratios were calculated, expressed as cost per live birth, in order to compare the cost–effectiveness of CC and IUI with that of EM to treat unexplained infertility.
RESULTS Live birth rates in the three randomized groups were: EM = 32/193 (17%), CC = 26/194 (13%) and IUI = 43/193 (22%). The mean (standard deviation) costs per treatment cycle were £0 for EM, £83 (£17) for CC and £98 (£31) for IUI. The mean treatment costs per patient for EM, CC and IUI were £12 (£117), £350 (£220) and £331 (£222), respectively. The cost per live birth for EM, CC and IUI was £72 (95% confidence interval £0–£206), £2611 (£1870–£4166) and £1487 (£1116–£2155), respectively. The incremental cost–effectiveness ratio for IUI versus EM was £5604 (−£12204 to £2227), with CC dominated by IUI.
CONCLUSIONS Despite being more expensive, existing treatments such as empirical CC and unstimulated IUI do not offer superior live birth rates compared with EM of unexplained infertility. They are unlikely to be a cost-effective use of limited NHS resources. The study's main limitation is that it did not consider the psychological effects on couples.
- expectant management
- unexplained infertility
- clomifene citrate
- intrauterine insemination