Methods |
Randomised controlled trial |
Participants |
20 women with PCOS undergoing IVF. |
Interventions |
10 mg of prednisolone administered daily until the day of hCG administration, versus placebo |
Outcomes |
Live birth rate per woman/couple; clinical pregnancy rate per woman/couple; multiple pregnancy rate per woman; miscarriage rate per woman; OHSS per woman; side‐effects per woman. |
Notes |
Miscarriage data (incomplete) were supplied by trial authors. We imputed one miscarriage in the prednisolone group. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
"Patients were randomized at down‐regulation in a double‐blind fashion to receive either placebo or prednisolone tablets from jars coded at the hospital pharmacy. The codes were revealed after treatment of the last patient." No further details, despite our contact with the authors. |
Allocation concealment (selection bias) |
Low risk |
10 patients in experimental and 10 patients in the control group; patients were randomised at down‐regulation; double‐blinding/ "Patients received either placebo or prednisolone from jars coded at the hospital pharmacy. The codes revealed after last patient received treatment." Further detail regarding exact methodology was given after personal communication with corresponding author. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blinding/patients received either placebo or prednisolone from jars coded at the hospital pharmacy; codes revealed after last patient received treatment. Further detail was given after personal communication with corresponding author. |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
No detection bias existed, as outcome was assessed in a blinded way. That information was given after personal communication with corresponding author. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
One woman in the control group was excluded from the study: "because of monofollicular growth, oocyte retrieval was never performed". Outcomes reported in the study for 19/20 randomised women. |
Selective reporting (reporting bias) |
Low risk |
No selective reporting detected |
Other bias |
Low risk |
No other bias detected |