Tremellen 2000.
Methods | Multicentre, parallel group study Randomisation stratified for centre, hence for fresh or frozen embryo transfer Number of women randomised: 600 (302 in the intervention group; 298 in the control group) Number of cancellations: 122 cycles (60 in the intervention group, 62 in the control group) which did not reach embryo transfer Number of cycles analysed: 478 |
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Participants | Country of authors: Spain and Australia Inclusion criteria: women aged 18 to 40 years, in a stable relationship, undergoing ART with fresh (in the Spanish centre) or frozen (in the Australian centre) embryo transfer Exclusion criteria: hepatitis B, or C or HIV positivity in the male partner Mean age ± SD: Spanish centre: intervention group: 33.3 ± 3.3 years, control group: 33.2 ± 3.3 years; Australian centre: intervention group: 33.8 ± 4.4 years, control group: 33.1 ± 4.4 years Mean duration of infertility ± SD: Spanish centre: intervention group: 4.7 ± 2.6 years, control group: 4.1 ± 2.8 years; Australian centre: intervention group: 5 ± 2.5 years, control group: 5.1 ± 2.8 years Women with primary infertility: not reported Setting: assisted reproduction programmes in Spain (Valencia and Murcia Clinics of the Instituto Valenciano de Infertilidad) and Australia (University of Adelaide Reproductive Medicine Unit) |
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Interventions | Interventions: fresh ART cycles in Spain: vaginal intercourse at least twice, 12 hours before oocyte pick up and 12 hours after embryo transfer Frozen embryo transfer cycles in Australia: vaginal intercourse at least once, during the period between four days before and two days after embryo transfer Comparator: abstinence during the same period. |
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Outcomes | Biochemical pregnancy, clinical pregnancy at 6 to 8 weeks of gestation, multiple pregnancy | |
Notes | We contacted the corresponding author, who understandably did not have the missing data for this trial, which was published 18 years ago. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated block randomisation list stratified for centre |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes managed by 3rd party |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded, though they were asked about adherence to the protocol |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objectively measured outcome |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 25% of cycles cancelled after randomisation. However, the proportion of cancelled cycles were similar between the groups and ITT analysis was done. |
Selective reporting (reporting bias) | Low risk | Clinical pregnancy reported |
Other bias | High risk | Significantly more embryos transferred in the control group |