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BACKGROUNDFirst-line treatments for unexplained infertility traditionally include clomifene citrate (CC) or unstimulated intrauterine insemination (IUI). A recently published randomized controlled trial considered the effectiveness of CC and IUI in patients with unexplained infertility and found that neither treatment offered a superior live birth rate when compared with expectant management (EM). This paper reports the economic evaluation conducted alongside this trial in order to assess whether health care providers are gaining value for money in this clinical area.METHODSFive 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 costeffectiveness ratios were calculated, expressed as cost per live birth, in order to compare the costeffectiveness of CC and IUI with that of EM to treat unexplained infertility.RESULTSLive 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 costeffectiveness ratio for IUI versus EM was £5604 (-£12204 to £2227), with CC dominated by IUI.CONCLUSIONSDespite 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 studys main limitation is that it did not consider the psychological effects on couples. © 2010 The Author.

Original publication




Journal article


Human Reproduction

Publication Date





369 - 375