Lisi 2012

Methods	Randomised open‐label, multicentre pilot study
Participants	Infertile women undergoing IVF/ICSI, mean age 34.4 ± 3.4 (n = 100) Exclusion criteria: women with PCOS, with any endocrine or metabolic disease, taking any hormonal treatment, with BMI > 30 kg/m2
Interventions	1. Myo‐inositiol 4000 mg: "into two administrations per day" + folic acid 400 µg: 1 tablet a day (n = 50) 2. Folic acid 400 µg: 1 tablet a day (n = 50) Duration of treatment 3 months, duration of trial 12 months
Outcomes	Length of stimulation Total quantity of gonadotropins required Number of oocytes retrieved Implantation rate Clinical pregnancy
Notes	Center for Reproductive Medicine Research, Clinica Villa Mafalda, Rome, Italy, study held from January 2011 to January 2012 Funding source not reported Emailed author 13th February 2013 regarding randomisation, allocation concealment and live birth data. Professor Lisi replied, clarifying these questions.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Block randomisation in a computer‐generated sequence" is written in the paper and in further correspondence from the author ..."About randomization, a computer software generated 100 numbers from 1 to 10,000, and the numbers were stored in sealed envelopes and opened on the day of preparation and explanation of the stimulation protocol to patients. Patients with odd number were assigned to folic acid, myo‐inositol and rhFSH; patients with even number were assigned to folic acid and rFSH". Unsure whether this may be quasi‐randomised. We sought further information from the author. Author replied, "The envelope outside had 100 numbers in order and opened in that order; numbers outside were different from numbers inside".
Allocation concealment (selection bias)	Low risk	Envelopes were numbered sequentially and were opaque
Blinding (performance bias and detection bias) All outcomes	High risk	Open‐label, although outcome assessors were blinded participants were not
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	No other bias found