Bellinge 1986.
Methods | Parallel group study Number of women randomised: 152 (78 in the intervention group; 74 in the control group) Number of women analysed: 113 |
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Participants | Country of authors: Australia Inclusion criteria: couples undergoing assisted reproduction with fresh ejaculate sperm Exclusion criteria: none reported Mean age (SD not stated): intervention group: 32.2 years; control group: 31.9 years Mean duration of infertility: not stated Women with primary infertility: not reported Setting: assisted reproduction programme in Western Australia |
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Interventions | Intervention: untreated fresh ejaculate was inseminated in the vagina at the time of oocyte fertilisation Control: women in both groups were instructed to abstain from vaginal intercourse 4 days before oocyte pick‐up |
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Outcomes | Clinical pregnancy defined as the presence of a gestational sac | |
Notes | We were unable to contact the authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table was used |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objectively measured outcome |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 10 to 30% of participants excluded after commencement, but similar proportions in both control and intervention groups. ITT analysis was presented |
Selective reporting (reporting bias) | Low risk | Clinical pregnancy rate reported |
Other bias | Low risk | No other cause of potential bias identified |