Fancsovits 2011

Methods	Parallel randomised controlled trial Prospective participant recruitment Consecutive participant sampling Single‐centre study performed at the Semmelweis University School of Medicine in Budapest, Hungary No strict inclusion or exclusion criteria No power calculation was performed Actual length of follow‐up per participant was four weeks after embryo transfer. Participants were enrolled in the trial between January 2006 and March 2007 and could participate in only one treatment cycle Study was commercially funded by Vitrolife No intention‐to‐treat analysis was performed
Participants	Mean age (SD): treatment group 35.7 (4.1), control group: 34.2 (4.6) years Type, cause and duration of subfertility not reported Number of previous IVF or ICSI treatments not reported Included participants could undergo IVF or ICSI for the trial An age analysis was performed; outcome data from participants 40 years of age or younger were compared with those from participants over 40 years of age 200 cycles were randomly assigned to a treatment group of 103 and a control group of 97. The total number of transferred embryos was 467: 238 in the treatment group and 229 in the control group
Interventions	Embryo transfer in EmbryoGlue (0.5 mg/ml HA) versus transfer in G‐2 (0.125 mg/ml HA). Embryos were incubated in EmbryoGlue or control medium for five to 10 minutes before transfer. Embryos in both groups were cultured in G‐1 and G‐2 until two to three days after fertilisation. The timing of the intervention was therefore early in embryo development. Randomisation was performed one day before embryo transfer. All culture and transfer media were manufactured by the same company—Vitrolife. All embryos were fresh, and oocyte donations were not included. The mean number of transferred embryos was 2.3 (± 0.8) in the treatment group and 2.4 (± 0.7) in the control group. Pregnancy was demonstrated via hCG pregnancy test and demonstration of a gestational sac on ultrasound
Outcomes	Primary outcomes Live birth rate, reported as the number of born babies. Not reported in original publication Secondary outcomes Clinical pregnancy rate, reported as the number of clinical pregnancies, demonstrated by positive pregnancy test and on ultrasound, divided by the number of cycles. Reported as percentages in original publication, raw data after contact with authors Additional outcomes Implantation rate, defined as number of implantations divided by number of transferred embryos. Reported as percentages in original publication, raw data after contact with authors
Notes	Conference abstract of a trial presented at ESHRE meeting in 2011. Additional data and study information were provided by the original investigator after contact was made with the authors of this review. See Appendix 8 In this trial, cycles instead of participants were randomly assigned; this is not compatible with data analysis that is part of this systematic review because of the possibility of participants enrolling with multiple cycles. However, after contact was made with the original investigator, it appeared that the number of multiple entries was less than 10% of the total number (seven in the treatment group and 12 in the control group), which was deemed acceptable by the review authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random allocation into treatment or control group, with randomisation achieved by a computer‐generated randomisation table
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Blinding of participant and clinician/nurse
Incomplete outcome data (attrition bias) All outcomes	High risk	Follow‐up was long enough Unclear whether any loss to follow‐up occurred No intention‐to‐treat analysis was performed
Selective reporting (reporting bias)	Low risk	Outcome measures were reported in a prespecified fashion. Of note, certain outcomes such as the live birth rate were not reported in the original publication but only after contact was made with the trial authors
Other bias	High risk	No commercial funding Culture media/environment in treatment and control groups comparable Multiple pregnancy rate not reported whilst multiple embryo transfer policy was followed