Soliman 1993.
| Methods | RCT; participant and provider could not be blinded. Follow‐up was 1 cycle in the IVF group and 6 months in the expectant management group | |
| Participants | 245 couples with infertility for 1 year, completed investigation for infertility, woman < 40 years. Mean duration of infertility 65 months, all previously treated by conventional means. Only 35 couples had unexplained infertility and are included in analysis in this review |
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| Interventions | IVF vs expectant management. Duration of expectant management was 6 months, during which time other treatments (apart from IVF) were permitted | |
| Outcomes | Pregnancy rate per woman/couple | |
| Notes | Computer‐generated random number table. 16 cycles (16.2%) cancelled after start of treatment for various reasons For couples randomly assigned to expectant treatment, any form of infertility treatment other than IVF was permitted for the 6‐months expectant management arm. 78% of couples received some form of infertility treatment except IVF while in the expectant arm Despite randomisation, a significant difference was noted between mean ages of participants in the 2 arms of the study |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was computer‐generated |
| Allocation concealment (selection bias) | Unclear risk | This was not mentioned |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No blinding was performed because of the nature of the intervention used |
| Incomplete outcome data (attrition bias) All outcomes | High risk | No intention‐to‐treat analysis was performed. 19% of participants overall withdrew (unclear how many with unexplained infertility withdrew) |
| Selective reporting (reporting bias) | Unclear risk | Information was insufficient for judgement of the trial as low risk or high risk |
| Other bias | High risk | Withdrawals were numerous; exact time of withdrawal was not defined, especially for the expectant management group. Groups were not balanced with regard to prognostic factors: IVF group were older and had higher proportion with endometriosis |