Chung 1995.
Methods | Trial design: parallel Single centre, UK | |
Participants | Couples with unexplained subfertility N randomised: 100 Age: IUI + OH 31.8 years (± 3.1); TI + OH 32.1 years (± 4.0) Duration of subfertility: IUI + OH 4.7 years (± 2.0); TI + OH 5.3 years (± 2.6) Basic fertility work‐up normal and semen 15 million motile per ejaculate Previous treatment: not stated |
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Interventions | Comparison: IUI + OH versus TI + OH Stimulation method: FSH 150 IU/day and GnRH nasal spray from day 21 on Ovulation: 5000 IU hCG when < 4 follicles > 16mm hCG post‐ovulatory for luteal support Timing TI: 24 hr + 48 hr after hCG Timing IUI: 36 hr to 48 hr after hCG Duration of treatment: 3 cycles max | |
Outcomes | PR per couple and per cycle Total delivered Multiple pregnancies Ectopic Miscarriage rate | |
Notes | ITT analysis: possible IUI was not possible on Sundays | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Blocked randomisation scheme |
Allocation concealment (selection bias) | Low risk | Adequate; numbered sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding was not possible because of the nature of the interventions |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding was not possible because of the nature of the interventions and non‐blinding was not likely to affect the outcomes of interest |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 8/50 withdrawn and 6 treatment cycles cancelled in TI group, 4/50 withdrawn and 11 treatment cycles cancelled in IUI group. Reason for cycle cancellation was excessive response. Reason for withdrawal was not stated |
Selective reporting (reporting bias) | Low risk | Live birth data and complication numbers were reported |
Other bias | Low risk | Nothing detected |