Methods | Randomised controlled trial | |
Participants | Women with primary infertility between 20 and 40 years undergoing IVF (n = 85) Inclusion criteria: regular menstruation, no hormonal or non‐hormonal drug therapy for less than 3 months and no systemic illness Exclusion criteria: serious endometriosis, serious male factor (azoospermia) hypogonadism with an FSH level < 13. Also participants with cycles cancelled were excluded. |
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Interventions | 1. Melatonin 3 mg: 1 tablet a day (n = 40) 2. No treatment (n = 45). |
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Outcomes | Primary outcome: number of morphologically mature oocytes retrieved (Mll oocytes) Secondary outcome: fertilisation rate, embryo quality and pregnancy rate |
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Notes | No information on miscarriage numbers Funding sources not mentioned Clinical pregnancy data (not chemical) used in the meta‐analysis Trial held in Turkey, study dates not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation computer‐assisted 1:1. |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment |
Blinding (performance bias and detection bias) All outcomes | High risk | Embyologist was the only person blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT used. No dropouts were reported |
Selective reporting (reporting bias) | High risk | Unclear why chemical pregnancy numbers are lower than clinical pregnancy numbers |
Other bias | Low risk | No other bias found |