Francavilla 2009.
| Methods | Design: cross‐over alternating Pre‐cross‐over data: not stated Power calculation: stated ITT: not stated Number of couples randomised: not stated Number of couples analysed: 73 Number of couples included in this review: 63 Number of started cycles: 384 Number of completed cycles: 384 Number of drop‐outs: not stated Number of cancelled cycles: none Centre: single centre, L'Aquila, Italy |
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| Participants | Couples: male subfertility (OAT) (n = 63), immunological subfertility (n = 10) Definition male subfertility: motile sperm count < 10 million/mL (due to oligozoospermia (< 20 million/mL), asthenozoospermia (< 50% progressive motility)), teratozoospermia (normal sperm morphology < 15%), immunological subfertility, or a combination of these Number of semen samples: ≥ 2 Age of women: ≤ 40 years Duration of subfertility: ≥ 2 years Primary/secondary subfertility: primary Ovulatory status: mid‐luteal phase progesterone ≥ 10 ng/mL, day 3 FSH < 10 IU/mL Tubal patency: HSG, DLS, or both PCT: done Previous treatment: not stated Exclusion criteria: < 1 million motile spermatozoa after semen preparation |
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| Interventions | Comparison: TI in natural cycles vs. IUI with OH cycles vs. IUI in natural cycles Treatment duration: maximum 9 cycles (6 IUI cycles) Method OH: CC 50 mg/day (cycle day 3‐7) and hMG 75 IU/day (cycle day 8 and 9) Timing of ovulation: LH surge urine or measurement of at least 1 follicle ≥ 20 mm when no LH surge was detected Ovulation induction (when no LH surge was detected): hCG 10,000 IU Number of IUI per cycle: 1 or 2 Timing IUI: the day after LH surge and in 2 consecutive days if the LH surge was detected in the evening or 39‐41 hours after hCG Timing intercourse: the day after LH surge Sperm preparation: swim up procedure Number of inseminated spermatozoa: not stated Cancellation criteria: not stated |
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| Outcomes | PR per completed cycle, authors supplied live birth rates per completed cycle OHSS: stated Miscarriage rate: stated Multiple PR: stated Ectopic PR: not stated Definition/diagnosis pregnancy: intrauterine gestational sac detected by USS |
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| Notes | Authors supplied unpublished pre‐cross‐over data. No stratification by diagnosis category of subfertility (male subfertility and immunological subfertility) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | High risk | On chronological basis |
| Blinding (performance bias and detection bias) All outcomes | Low risk | No blinding stated, but outcome was not likely to be influenced |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Authors supplied unpublished pre‐cross‐over data |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | High risk | Cross‐over design |