Koike 1999.
Methods | Randomised, placebo‐controlled trial, single centre, unpublished | |
Participants | 98 infertile women at risk of severe OHSS ( 43 albumin plus saline versus 55 saline alone) undergoing IVF/ICSI/GIFT > 20 oocytes were retrieved from patients at high risk.The estradiol in their serum was not measured Age (32.1 versus 31.0 years) Duration of infertility (not stated) No. of hMG ampoules (not stated) No. of oocytes (27 versus 26.1) No. of embryos (19 versus 17) |
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Interventions | Study group: 37.5 g albumin plus 1000 mL electrolyte solution just after oocyte retrieval Duration: consecutive 3 days Control group: 1000 mL electrolyte solution for consecutive 3 days | |
Outcomes | Method of diagnosing severe OHSS: marked haemoconcentration (haematocrit ≥ 45) and/or hypoproteinaemia (serum total protein < 6.0 g/dL) in addition to marked ascites on the upper abdomen at least 4 days after oocyte retrieval (Orvieto and Ben‐Rafael,1998) Severe OHSS: 13/43 versus 21/55 Pregnancy: 14/43 versus 24/55 Method of diagnosing pregnancy: serum β‐hCG Tolerability: not stated Safety: not stated Cost‐benefit: not stated | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table |
Allocation concealment (selection bias) | Unclear risk | Methods not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised women included in analysis |
Selective reporting (reporting bias) | Unclear risk | Adverse effects not reported as an outcome |
Other bias | Unclear risk | No other potential bias identified |