Methods | Prospective, randomised clinical trial | |
Participants | Women with low oocyte quality detected in previous IVF cycles (n = 65). Aged 35 ‐ 42 years. Mean age Treatment group 37.81 ± 2.61, Placebo 38.09 ± 1.97 IVF |
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Interventions | 1. Myo‐inositol 2 g + folic acid 200 mg + melatonin 3 mg: each tablet twice a day (n = 32) 2. Myo‐inositol 2 g + folic acid 200 mg: each tablet twice a day (n = 33) Administered continuously from the day of GnRH administration |
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Outcomes | Embryo quality Pregnancy rate, biochemical and clinical Total number of oocytes retrieved (immature and mature oocytes) Fertilisation rate per number of retrieved oocytes and embryo cleavage rate Spontaneous abortion defined as a pregnancy loss from 5 ‐ 12 weeks pregnancy |
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Notes | Setting: Messina, Italy, study dates not reported All participants gave written informed consent for the procedure, and the study was approved by the local ethics committee. Source of funding unclear. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised: "According to a randomisation table, patients were assigned to receive either 2 g..." |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
Selective reporting (reporting bias) | Low risk | Data given for all outcomes reported in the text |
Other bias | Low risk | No other bias found |