Karlstrom 1993.
| Methods | Trial design: parallel Single centre, Sweden | |
| Participants | Couples with unexplained subfertility and minimal or mild endometriosis N randomised: not clear; N analysed: 79 Age: 32 years (range 21 years to 38 years) Duration of subfertility: 5 years (range 2 years to 14 years) Basic fertility work‐up normal, semen normal according to WHO 1987 Previous treatment: no |
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| Interventions | Comparison: IUI + OH versus TI + OH (vs DIPI + OH vs IUI and DIPI + OH)
Stimulation method 1: 150 IU hMG starting dose, til 1 follicle of at least 17 mm was present or the detection of a LH surge in serum or urine
Monitoring: USS and serum E2
Ovulation: 10,000 IU hCG
Timing: IUI 36 hr to 41 hr after hCG or 24 hr after detection of LH surge. TI the 2 following nights after hCG injection Stimulation method 2: 100 mg CC/day for 5 days Monitoring + ovulation: urinary LH timed Timing: IUI 20 hr to 28 hr after LH surge, TI day of LH surge and day after Cycles were cancelled according to serum E2 rise Duration of treatment: 1 cycle max |
|
| Outcomes | PR per cycle Ectopic PR Pregnancy not further defined | |
| Notes | ITT analysis: not possible When ovulation occurred during the weekend, participants were transferred to TI group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| 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 | 4 withdrawals in clomiphene group due to absent LH surge, 5 withdrawals in hMG group due to absent LH surge, fast oestrogen rise or personal reasons |
| Selective reporting (reporting bias) | Unclear risk | Live birth data were not reported |
| Other bias | Unclear risk | Insufficient information was reported on demographic characteristics to make a conclusive judgement |