Skip to main content
. 2014 Feb 25;2014(2):CD007421. doi: 10.1002/14651858.CD007421.pub3
Methods Parallel randomised controlled trial
Prospective participant recruitment
Method of sampling of participants was unclear
Single‐centre trial performed at the Colorado Center for Reproductive Medicine in Englewood, Colorado, USA
Both IVF patients with their own oocytes and oocyte donors were included
Unclear whether a power calculation was performed
Participants were enrolled in this trial from January 2001 to February 2002. The exact length of follow‐up per participant was not stated, but it was long enough to permit measurement of the trial's proposed outcomes
Unclear whether an intention‐to‐treat analysis was performed
Unclear whether multiple treatment cycles or only one treatment cycle per participant were included in the trial
Trial was supported by Vitrolife
Participants A total of 175 IVF participants and oocyte donors were recruited for this trial. 141 of them were IVF patients, and 34 were oocyte donors. 91 participants were randomly assigned to the treatment group and 84 to the control group. No loss was reported, so the data on all 175 participants were analysed. Number of transferred embryos was unclear; only the mean number per group was published
Age: not reported
Not reported whether study concerned primary and/or secondary subfertility
Cause and duration of subfertility not reported
Trial studied only IVF participants, no participants receiving ICSI. Not reported whether participants had received previous IVF treatment
No age analysis was reported
Interventions Embryo transfer of participants' own or donated fertilised oocytes in G2.3 medium supplemented with EmbryoGlue (0.5 mg/ml HA) versus transfer in G2.3 medium (0.125 mg/ml HA)
All embryos were cultured in G1.3 medium
Timing of randomisation was unclear
Embryos were exposed to the higher concentration of HA just before transfer
Transfer was performed on day three of embryo development
Donor oocytes were included
Unclear whether embryos had to be fresh or if frozen‐thawed embryos were also included
All culture and transfer media were manufactured by Vitrolife
Mean number of embryos transferred: treatment IVF group 3.9, treatment donor oocytes 3.9; control IVF group 3.3, control donor oocytes 3.2
Pregnancy and implantation rates were determined by demonstration of fetal heartbeat
Outcomes Secondary outcomes
  • Clinical pregnancy rate: presented as percentage, with number of participants in study group as the denominator


Additional outcomes
  • Implantation rate: presented as percentage; denominator was unclear. No raw data available

Notes Abstract of ASRM conference presentation
The primary author was contacted regarding unclear details in published abstract, but further participation was declined. So some uncertainty cannot be resolved
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation into treatment or control group by a computer‐generated randomisation sheet
Allocation concealment (selection bias) Unclear risk Allocation was correctly performed, but concealment was unclear
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Blinding was unclear
Incomplete outcome data (attrition bias) 
 All outcomes High risk No live births were reported. Length of follow‐up per participant was unclear. No intention‐to‐treat analysis was reported
Selective reporting (reporting bias) Low risk Clinical pregnancy and implantation rates were reported in a prespecified way
Other bias High risk Trial was commercially funded by Vitrolife. Same transfer media brand was used in treatment and control groups. Transfer media were comparable, with the addition of EmbryoGlue to the treatment group. No multiple pregnancy rate was reported, although multiple embryos were transferred per cycle