Deaton 1990.
| Methods | Trial design: cross‐over (after 4 cycles) Single centre, USA | |
| Participants | Couples with unexplained subfertility and couples with surgically treated endometriosis N randomised: 67; N analysed: 51 total, unexplained: 24 Age: 33 years (± 4.0) Duration of subfertility: 3.5 years (±1.7) Basic fertility work‐up normal, semen normal according to WHO criteria 1987 Previous treatment: not stated |
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| Interventions | Comparison: IUI + OH versus TI + NC
Stimulation method: 50 mg CC/day, day 5 to day 9 Timing: Natural cycle: urinary LH and BBT timed intercourse Stimulated cycle: 10,000 IU hCG when lead follicle was estimated to be at least 18 mm. IUI 36 hr after hCG injection No cancellation criteria were given Duration of treatment: 8 cycles max |
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| Outcomes | Ongoing pregnancy rate
Multiple pregnancies
Ectopic pregnancies
Miscarriage rate
OHSS Pregnancy: not further defined |
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| Notes | ITT analysis: not possible Participants with unexplained subfertility and endometriosis were included in this study; 3 participants with moderate and no participants with severe endometriosis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Sequence generation not stated |
| Allocation concealment (selection bias) | Unclear risk | Unclear |
| 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 | Low risk | 16/67 participants excluded from analysis due to anovulation, poor semen quality or inability to follow the treatment protocol. Of the remaining 51 participants, 6 couples did not complete treatment because of illness or relocation. 4/51 dropped out before cross‐over |
| Selective reporting (reporting bias) | Unclear risk | Live birth rate was not reported |
| Other bias | Unclear risk | Insufficient information available to evaluate this risk domain |