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. 2018 Feb 28;2018(2):CD011809. doi: 10.1002/14651858.CD011809.pub2

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
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)
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.
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