Methods | Single‐centre, prospective randomised study ("randomly divided in two groups") Cabergoline vs no medication Setting: Tunisia |
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Participants | 146 women undergoing IVF or ICSI and receiving GnRHa. OHSS risk defined as a plasma E2 level > 3000 pg/mL on the day of hCG administration or the development of ≥ 18 follicles > 12 mm in diameter, or both Exclusion criteria: coasting cases, aged > 40 years, history of uterine surgery, and submucosal and intramural fibromas > 5 cm Cabergoline group: 78 women Control group: 68 women |
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Interventions | Cabergoline group: cabergoline 0.5 mg/day for 8 days starting on the day of hCG injection Control group (no intervention): no medication treatment |
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Outcomes | Moderate and severe OHSS identified according to the criteria of Golan and colleagues (Golan 1989)
Live birth rate: not stated Miscarriage rate: only reported for women who developed OHSS (cabergoline group vs control group): 3/25 vs 6/25 Clinical pregnancy rate only reported for women who developed OHSS (cabergoline group vs control group): 20/25 vs 14/25 Multiple pregnancy rate: not stated Any other adverse effects of the treatment: not stated |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Lack of information to permit judgement |
Allocation concealment (selection bias) | Unclear risk | Lack of information to permit judgement |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Lack of information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | High risk | No follow‐up data from the non‐OHSS women in both groups, no data on possible loss to follow‐up or dropout |
Selective reporting (reporting bias) | High risk | Pregnancy data from the non‐OHSS women in both groups not reported |
Other bias | High risk | Coasting cases (women at highest risk for severe OHSS) were excluded, unclear based on what criteria coasting was opted for |