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. 2016 Aug 31;2016(8):CD001302. doi: 10.1002/14651858.CD001302.pub3

Bellver 2003.

Methods Randomised controlled trial
 Parallel design
 Single centre
Not blind
Power calculation: done
Participants 988 women (infertile women n = 605 and donors n = 383) who were all considered to be at risk of moderate or severe OHSS (495 albumin/493 control)
 > 20 retrieved oocytes was the basic risk factor of OHSS
 Age (29.9 versus 29.7years)
 Duration of infertility (not stated)
 No. of FSH and hMG ampoules (not stated)
 No. of oocytes (28.7 versus 27.8)
 No. of embryos (15 versus 19)
No. of transferred embryos (2.8 versus 3.0)
Interventions Study group: 40 g human albumin infused intravenously at a slow rate, immediately after oocyte retrieval
Duration: during 30 min
 Control group: no treatment
Outcomes Method of diagnosing severe OHSS: criteria for (Golan 1989)
Severe OHSS: 25/495 versus 23/493
 Pregnancy: 138/298 versus 166/307
 Method of diagnosing pregnancy: fetal heart rate
Tolerability: yes
 Safety: yes
 Cost‐benefit: stated (195 euros/patient)
Notes Two kinds of GnRH agonist were used and only early OHSS was assessed. Placebo was not used in their control group, which eliminates the placebo effect of albumin administration. Serum E2 level, which was previously reported as an independent risk factor for severe OHSS, was not considered a high‐risk factor in this study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated
Allocation concealment (selection bias) Unclear risk Method not reported
Blinding (performance bias and detection bias) 
 All outcomes High risk Not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 966/988 (98%) randomised women included in analysis
Selective reporting (reporting bias) Unclear risk Unclear whether data on adverse events were collected prospectively as it was not a prespecified outcome, though mentioned in the discussion section
Other bias Low risk No other potential bias identified
HHS Vulnerability Disclosure