Methods |
RCT using permuted blocks of varying sizes, stratified by woman's age (< 35 vs ≥ 35 years), laparoscopy within past year (yes or no) and study site (Boston IVF or Harvard Vanguard Medical Associates). Allocation sequence was produced by random numbers generated by a congruence method. Investigators were blinded to all outcome determinations |
Participants |
503 couples; women 21 to 39 years of age with unexplained infertility and mild male factor of 12 months' duration |
Interventions |
Couples in this study were randomly assigned to conventional pathway involving clomiphene citrate plus intrauterine insemination (CC + IUI) followed by IUI + gonadotropins and then IVF; or accelerated pathway (CC + IUI followed by 6 cycles of IVF) |
Outcomes |
Pregnancy rate per cycle, pregnancy rate per couple, LBR per cycle, LBR per couple, time to pregnancy, charge data |
Notes |
Study could not be included for comparison between IVF and IUI + CC, as both arms received CC + IUI |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"The allocation sequence was produced by use of random numbers generated by a congruence method. The sequence was developed by the biostatistician
and implemented by the epidemiologist" |
Allocation concealment (selection bias) |
Low risk |
Apparently remote allocation: "The sequence was ...implemented by the epidemiologist" |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Investigators were blinded to all outcome determinations; allocation was performed by a biostatistician and was implemented by an epidemiologist |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
503/503 randomly assigned women analysed by intention‐to‐treat |
Selective reporting (reporting bias) |
Low risk |
Study authors published preliminary results in 2007 and did not appear to publish or failed to publish based on results of the trial |
Other bias |
Low risk |
No other potential biases could be detected |