Methods | Parallel, single‐centre randomised controlled trial Computer‐based randomisation Cabergoline vs no intervention Setting: Brazil |
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Participants | 166 women undergoing IVF and ICSI treatment and at risk of developing OHSS, defined as serum E2 > 4000 pg/mL on the day of hCG administration Exclusion criteria: not stated Cabergoline group: 83 women Control group: 83 women, 3 women were withdrawn for not completing the follow‐up tests No differences between groups in age or BMI Did not report the duration of infertility and causes of infertility |
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Interventions | All participants received routine preventive IV HA 20 g on the day of oocyte retrieval Cabergoline group: cabergoline 0.5 mg/day for 3 weeks from the day after oocyte retrieval Control group: no intervention |
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Outcomes | Moderate and severe OHSS identified by the modified classification of Golan and colleagues (Golan 1989)
Live birth rate: not stated Miscarriage rate (cabergoline group vs control group): 1/83 vs 3/83 Clinical pregnancy rate (cabergoline group vs control group): 33/83 vs 32/83 Multiple pregnancy rate (cabergoline group vs control group): multiple pregnancies were documented in all the severe cases of OHSS in both groups (2/83 vs 1/83) Any other adverse effects of the treatment: not stated |
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Notes | Authors reported no financial or commercial conflicts of interest | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐based randomisation |
Allocation concealment (selection bias) | Unclear risk | Lack of sufficient information to permit judgement |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Lack of sufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3/200 women in control group could not complete their follow‐up |
Selective reporting (reporting bias) | Unclear risk | No exclusions (no live birth rated mentioned) |
Other bias | Unclear risk | Lack of sufficient information to permit judgement |