Ciotta 2011

Methods	Randomised controlled trial
Participants	Women with PCOS attending a fertility clinic－Gynaecological Endocrinology Clinics and Human Reproduction Pathophysiology Centre (n = 34) Inclusion criteria: women with PCOS younger than 40 years Exclusion criteria: concomitant endocrine and metabolic pathologies, such as hypothyroidism, hyperthyroidism, diabetes mellitus, androgen‐secreting cancers, adrenal hyperplasia, Cushing's syndrome Women received IVF or ICSI after evaluation of sperm analysis
Interventions	1. Myo‐inisitol 2 g + folic acid 200 µg: 1 tablet of each twice a day (n = 16) 2. Folic acid 200 µg: 1 tablet twice a day (n = 18) Treatment was given over 3 months
Outcomes	Number of follicles Number of oocytes retrieved Number of embryos transferred Embryo quality Study states that there was "no difference in the total number of biochemical pregnancies detected", but no data were provided. Author replied, giving the data for chemical pregnancies and stating that no adverse events were reported
Notes	Trial held in Catania, Italy Contacted authors 21st November 2011 via letter and email regarding pregnancy data, allocation concealment and who was blinded. Author responded 28th November 2011 Emailed the author 5th February 2012 requesting data on clinical pregnancies and whether the sealed envelopes were numbered. No reply Funding, ethics approval and power calculation not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"According to a randomisation table, patients were divided into two groups".
Allocation concealment (selection bias)	Unclear risk	Author states that allocation was in "white sealed envelopes".
Blinding (performance bias and detection bias) All outcomes	Low risk	"the investigation was performed in a double‐blind design". Author states, "clinicians and patients were blinded".
Incomplete outcome data (attrition bias) All outcomes	Low risk	No women were lost to follow‐up
Selective reporting (reporting bias)	Low risk	Outcomes reported
Other bias	Low risk	No other bias found