Aflatoonian 2009.
Methods | Parallel group study Number of women randomised: 390 (195 in the intervention group; 195 in the control group) Number of women analysed: 385 |
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Participants | Country of authors: Iran Inclusion criteria: couples undergoing assisted reproduction with at least 5 years of subfertility Exclusion criteria: none reported Mean age ± SD: intervention group: 29.4 ± 4.4 years; control group: 29.6 ± 4.9 years Mean duration of infertility ± SD: intervention group: 8.7 ± 3.8 years; control group: 9.0 ± 3.9 years Women with primary infertility: not reported Setting: assisted reproduction programme in Iran |
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Interventions | Intervention: vaginal intercourse at least once during the 12 hours following embryo transfer Control: abstinence during the entire ART cycle |
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Outcomes | Clinical pregnancy defined as the presence of a gestational sac or fetal cardiac activity three weeks after embryo transfer | |
Notes | Pregnancy outcome was unknown for five women in the intervention arm. The corresponding author was contacted but was not able to provide missing data either for the five women with unknown primary outcome or other unreported outcome measures. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Equal number of paper slips for each method put in a bag |
Allocation concealment (selection bias) | Low risk | Drawing paper slips from the bag on the day of embryo transfer |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Couples in the control group could have had intercourse without informing the investigators and contaminated the results |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objectively assessed outcome measure |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Pregnancy outcome missing for 5 women in the intervention group |
Selective reporting (reporting bias) | Low risk | Clinical pregnancy rate was reported |
Other bias | Low risk | No other cause of potential bias identified |