Konig 1998.
Methods | Randomised, placebo‐controlled, double blind | |
Participants | 104 infertile women at risk of severe OHSS (53 HES/51 control) E2 the basic risk factor of OHSS) was > 1500 pg/mL and more than 10 follicles on the day of hCG injection Age (HES 32.6 versus placebo 30.7 years) Duration of infertility (not mentioned) No. of hMG ampoules (not mentioned, similar in both groups ) No. of oocytes (not mentioned, similar in both groups) No. of embryos (not mentioned) | |
Interventions |
Study group: 1000 mL of 6% HES solution shortly after embryo transfer (48 hr after the oocyte retrieval) originally 104 pt randomised: HES 53 control 51; data presented only for 51 and 50 patients respectively. dropout 2.9% (3 women; 2 missing data, 1 allergic reaction) Duration of infusion: over 2 hours Control group: 1000 mL NaCl 0.9% solution |
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Outcomes | Method of diagnosing severe OHSS: criteria of WHO, 1973 Severe OHSS 0/53 versus 1/51 Pregnancy: not stated but similar between both group Method of diagnosing pregnancy: not stated (clinical pregnancy) Tolerability: yes Safety: one case of urticaria Cost‐benefit: not stated | |
Notes | Commercially funded | |
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 | Double blinded; both patients and physicians blinded, but outcome assessors not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 101/104 (97%) randomised women were 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 results section |
Other bias | Unclear risk | No other potential bias identified |