Hughes 2004.
| Methods | 139 women in a multi‐centre randomised controlled trial (RCT). Randomisation was based on a blocked schedule using numbered, sealed, opaque envelopes and stratified by centre; female age (≥ 35 years) and presence or absence of abnormal sperm (total sperm count ≥ 20 million). Power calculation done. Intention‐to‐treat analysis performed. Fisher's exact test used for analysis. Confidence intervals calculated using Mantel‐Haenszel statistics | |
| Participants | Duration of subfertility ≥ 2 years (defined as no live birth during that time), no previous IVF treatment, female age 18 to 39 years, day 3 serum follicle‐stimulating hormone (FSH) level ≥ 15 IU/L or standard level for inclusion in an individual centre's IVF programme, whichever level was lower; semen analysis within past 6 months showing adequate sperm number to perform intracytoplasmic sperm injection (ICSI), evidence of tubal patency by hysterosalpingography or laparoscopy Mean duration of subfertility was 58 months. All couples had exhausted appropriate lower intensity treatment options, such as ovulation induction and intrauterine insemination. |
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| Interventions | First cycle of IVF compared with 90 days of no treatment (expectant management) | |
| Outcomes | Clinically viable pregnancy rate per couple, LBR per couple | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | States: "Random allocation was based on a blocked schedule using numbered, sealed, opaque envelopes" |
| Allocation concealment (selection bias) | Low risk | "Random allocation was based on a blocked schedule using numbered, sealed, opaque envelopes" |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | This was not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 68/68 randomly assigned women analysed by intention‐to‐treat |
| Selective reporting (reporting bias) | Low risk | Study reported primary and secondary treatment outcomes adequately including adverse outcomes |
| Other bias | High risk | Pre‐study power calculation was performed,.and no other potential bias could be observed |