Bellver 2003.
Methods | Randomised controlled trial
Parallel design
Single centre Not blind Power calculation: done |
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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) |
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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 |
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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) |
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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 |