Steures 2006a.
| Methods | Trial design: parallel Multicentre: 26 fertility centres in the Netherlands | |
| Participants | Couples with unexplained subfertility and an intermediate prognosis of conceiving within the next 12 months (Hunault 30% to 40%) N randomised: 253; IUI + OH 127; TI (expectant management) + NC 126 Age: IUI + OH 33 years (± 3.4); TI + NC 33 years (± 3.19) Duration of subfertility: IUI + OH 2.0 years (± 0.5);TI + NC 1.91 years (± 0.5) Basic fertility work‐up done, semen analysis according to WHO 1987, normal postcoital test Previous treatment: not stated |
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| Interventions | Comparison: IUI + OH versus TI (expectant management) + NC
Stimulation method: FSH 37 to 150 IU/day or 50 mg to 150 mg CC/day
Monitoring: USS
Ovulation: 5000 or 10,000 IU hCG
Timing: IUI 36 hr to 40 hr after hCG Cycles were cancelled when > 3 follicles of 16 mm or > 5 follicles of 12 mm were present Duration of treatment: 6 months |
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| Outcomes | Live birth/couple PR/couple Miscarriage rate Multiple pregnancies | |
| Notes | ITT analysis: yes
Author provided additional information Only couples with an intermediate prognosis of conceiving were included, so this influences the possible treatment effect |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated sequence in balanced blocks |
| Allocation concealment (selection bias) | Low risk | Adequate; via opaque 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 | Low risk | IUI + OH group, 3 participants lost to follow‐up, TI + NC group, 2 lost to follow‐up, 2 still pregnant |
| Selective reporting (reporting bias) | Low risk | Live birth and complications reported |
| Other bias | Low risk | Nothing detected |
ART: assisted reproductive technology CC: clomiphene citrate DIPI: direct intraperitoneal insemination EM: expectant management FSH: follicle stimulating hormone hCG: human chorionic gonadotropin hMG: human menopausal gonadotropin hr: hour(s) ITT: intention‐to‐treat IUI: intra‐uterine insemination OH: ovarian hyperstimulation PR: pregnancy rate USS: ultrasound scan