Methods | Double‐blind randomised controlled trial | |
Participants | Infertile women aged > 40 years undergoing IVF (n = 358) | |
Interventions | 1. Melatonin 5 mg: 1 tablet a day (n = 178) 2. No treatment (n = 180) Trial ran from July 2009 to December 2013 |
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Outcomes | Oocyte maturity Oxidative stress Antioxidative capacity Progesterone concentration in follicular fluid Embryo grade |
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Notes | Conducted in Italy, trial ran from July 2009 to Decenber 2013 Trial funded by pharmaceutical company Trial registration no: NCT01540747 Email sent to Dr Pacchiarotti regarding the methods of this trial. Dr Pacchiarotti replied 20th March 2017 giving some methods information |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Unclear risk | Unknown |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double‐blind but control is no treatment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unknown |
Selective reporting (reporting bias) | Low risk | No known selective reporting |
Other bias | Low risk | No other bias found |