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. 2017 Jul 28;2017(7):CD007807. doi: 10.1002/14651858.CD007807.pub3
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.
Interventions 1. Melatonin 3 mg: 1 tablet a day (n = 40)
2. No treatment (n = 45).
Outcomes Primary outcome: number of morphologically mature oocytes retrieved (Mll oocytes)
Secondary outcome: fertilisation rate, embryo quality and pregnancy rate
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
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