Methods | Single‐centre randomised controlled trial Computer‐based randomisation by independent research assistant Cabergoline vs coasting Setting: India |
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Participants | 60 women undergoing IVF or ICSI cycles and at risk of developing OHSS, defined as the presence of preovulatory follicles ≥ 20 in both ovaries and the E2 level ≥ 2500 pg/mL Exclusion criteria: not stated Cabergoline group: 30 women Coasting group: 30 women |
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Interventions | Cabergoline group: cabergoline 0.5 mg/day orally from the day of hCG for 8 days Coasting group: gonadotropins were withheld (while GnRHa was maintained), until the serum level of E2 started to decline in each group. 1 woman needed ascites tapped, and the remaining 29 women received 6% HES infusion |
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Outcomes | Moderate and severe OHSS: classification not described but according to Golan (Golan 1989) criteria (from private correspondence with author)
Live birth rate: not stated Miscarriage rate (cabergoline group vs coasting group): 0/30 vs 2/30 Clinical pregnancy rate (defined as presence of gestational sac or cardiac activity 3 weeks after transfer) (cabergoline group vs coasting group): 8/30 vs 4/30 Multiple pregnancy rate (cabergoline group vs coasting group): 2/30 vs 0/30 Any other adverse effects of the treatment: cancelling of ET due to poor embryo quality (cabergoline group vs coasting group): 1/30 vs 1/30. Other adverse events not stated |
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Notes | Received draft of full‐text article in peer review currently per private email; additional information per private correspondence with first author. 58 women received fluid of 6% HES and the remaining included woman received an ascites tap instead of HES. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Use of randomisation software (www.randomizer.org/) |
Allocation concealment (selection bias) | Unclear risk | Independent research assistant allocated; concealment unclear |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding involved. The participants and clinicians were aware in which arm of the study they were |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts/loss of follow‐up in the 2 groups |
Selective reporting (reporting bias) | Unclear risk | No exclusions (no live birth rated mentioned) |
Other bias | High risk | OHSS identified/classification not described. 29 participants in both groups also received HES infusion, 1 participant from each group had ascites tap, unclear which participant was involved |