In an RCT 1 253 couples with unexplained subfertility and a 30-40% probability of a spontaneous ongoing pregnancy within 12 months were randomly assigned either to intrauterine insemination with controlled ovarian hyperstimulation (IUI-OS) for 6 months or to expectant management (EM) for 6 months. In the intervention group, 42/127 (33%) women conceived and 29 (23%) pregnancies were ongoing. In the expectant management group, 40/126 (32%) women conceived and 34 (27%) pregnancies were ongoing (RR 0.85, 95% CI 0.63-1.1). There was one twin pregnancy in each study group, and one woman in the intervention group conceived triplets.
In 3 years follow-up of the above mentioned RCT 3 the effectiveness and cumulative costs were assessed. Time to ongoing pregnancy did not differ between groups (log-rank test P=0.98). Cumulative ongoing pregnancy rates were 72-73% for EM and IUI-OS groups, respectively (RR 0.99, 95% CI 0.85 to 1.1). Estimated mean costs per couple were € 3424 (95% CI € 880-€ 5968) in the EM group and € 6040 (95% CI € 4055-€ 8125) in the IUI-OS group resulting in an estimated saving of € 2616 per couple (95% CI € 385-€ 4847) in favour of EM.
A network meta-analysis 4 included 27 RCTs with 4 349 couples. Ten RCTs including 2 725 couples reported on live birth. For differences between OS, IUI, OS-IUI, or vitro fertilisation with or without intracytoplasmic (IVF/ICSI) versus expectant management see table (table T1). This suggests that if the chance of live birth following expectant management is assumed to be 17%, the chance following OS, IUI, OS-IUI, and IVF would be 9% to 28%, 11% to 33%, 15% to 37%, and 14% to 47%, respectively. When only including couples with poor prognosis of natural conception (3 trials, 725 couples) OS‐IUI and IVF/ICSI increased LBR compared to expectant management (OR 4.48, 95% CI 2.00 to 10.1; moderate‐certainty evidence; OR 4.99, 95 CI 2.07 to 12.04; moderate-certainty evidence), while there was insufficient evidence of a difference between IVF/ICSI and OS-IUI (OR 1.11, 95% CI 0.78 to 1.60; low-certainty evidence).Compared to expectant management, other treatments increased the odds of multiple pregnancy (11 RCTs, 2564 couples).
| Outcome: Live birth rate or ongoing pregnancy | Assumed riskwith comparatorExpectant management | Risk with intervention | Relative effect(95% CI) | Numbe of couples (Studies)Quality of evidence |
|---|---|---|---|---|
| 166 per 1000 | OS 167 per 1000(92 to 282) | OR 1.01(0.51 to 1.98) | 527 (2)Low | |
| 166 per 1000 | IUI 194 per 1000(108 to 325) | OR 1.45(0.61 to 2.43) | 386 (1) Low | |
| 166 per 1000 | OS-IUI 242 per 1000(149 to 369) | OR 1.61(0.88 to 2.94) | 454 (2) Low | |
| 166 per 1000 | IVF/ICSI272 per 1000(139 to 465) | OR 1.88(0.81 to 4.38) | only indirect evidence used hereLow |
Comment: The quality of evidence is downgraded by imprecise results (few patients and wide confidence intervals).
Primary/Secondary Keywords