Busso 2010.

Study characteristics
Methods	Randomised, parallel, double‐blind randomised controlled trial Quinagolide vs placebo Setting: Spain
Participants	182 women undergoing IVF and ICSI treatment and at risk of developing OHSS with ≥ 20 follicles ≥ 10 mm on day of hCG administration Exclusion criteria: > 30 follicles or serum E2 > 6000 pg/mL (or both) had cycle cancellation, previous coasting in this cycle, any clinically significant systemic disease, endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney), history of recurrent miscarriage, undiagnosed vaginal bleeding Quinagolide 50 μg group: 51 women Quinagolide 100 μg group: 52 women Quinagolide 200 μg group: 26 women Control group: 53 women
Interventions	4 tablets for every woman (combination of placebo/quinagolide 50 μg) Quinagolide 50 μg group: quinagolide 50 μg + 3 placebo tablets once daily, continuing until day before serum hCG test which took place 17+2 days after oocyte retrieval Quinagolide 100 μg group: quinagolide 100 μg + 2 placebo tablets once daily, continuing until day before serum hCG test which took place 17+2 days after oocyte retrieval Quinagolide 200 μg group: quinagolide 200 μg + no placebo tablets once daily, continuing until day before serum hCG test which took place 17+2 days after oocyte retrieval Control group: 4 placebo tablets once daily, continuing until day before serum hCG test which took place 17+2 days after oocyte retrieval
Outcomes	Moderate and severe OHSS identified by the modified classification of Golan and colleagues (Golan 1989) Moderate/severe OHSS (quinagolide 50 μg group vs quinagolide 100 μg group vs quinagolide 200 μg group vs placebo group): 6/51 vs 7/52 vs 1/26 vs 12/53 Live birth rate (quinagolide 50 μg group vs quinagolide 100 μg group vs quinagolide 200 μg group vs placebo group): 23/51 vs 29/52 vs 14/26 vs 27/53 Miscarriage rate: not stated Clinical pregnancy rate (quinagolide 50 μg group vs quinagolide 100 μg group vs quinagolide 200 μg group vs placebo group): 22/51 vs 26/52 vs 11/26 vs 27/53 Multiple pregnancy rate: not stated Discontinued because of adverse events (quinagolide 50 μg group vs quinagolide 100 μg group vs quinagolide 200 μg group vs placebo group): 3/51 vs 7/52 vs 7/26 vs 0/53 Any other adverse effects of the treatment: nausea, dizziness, somnolence, diarrhoea, vomiting, lower abdominal pain, headache, abdominal distension, flatulence, upper abdominal pain, syncope
Notes	Sponsored by Ferring Pharmaceuticals WHO registry reference: EUCTR2006‐000415‐15‐ES
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list prepared for each centre by a statistician not involved in the trial, and based on this the clinics were provided with individual code envelopes that were sealed to conceal the treatment group allocation.
Allocation concealment (selection bias)	Low risk	Computer‐generated randomisation list provided to the clinics with individual code envelopes that were sealed to conceal the treatment group allocation. Block size was not disclosed.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double blind (participants, staff, and trial sponsor). All participants received 4 tablets (medication or placebo, or both).
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Lack of information to permit a judgement.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Systematic OHSS evaluation performed; high‐dose arm stopped after poor tolerability of high‐dose medication.
Selective reporting (reporting bias)	Low risk	Most of outcomes were evaluated.
Other bias	High risk	Poor tolerability of high dose could have revealed allocated group. Sponsored by Ferring Pharmaceuticals. Very high‐risk women (> 30 follicles or serum E2 > 6000 pg/mL, or both) excluded and underwent cycle cancellation.