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. 2017 Jul 28;2017(7):CD007807. doi: 10.1002/14651858.CD007807.pub3
Methods vRandomised study
Participants Women with PCOS indicated by oligomenorrhoea and/or hyperandrogenism and/or hyperandrogaenemia and/or typical features of ovaries on ultrasound scan were enrolled in this study. At least 2 of the above‐mentioned criteria were present in all the participants
Women were undergoing IVF and aged < 40 years (n = 29)
Exclusion criteria: any other medical conditions causing ovulatory disorders such as hyperprolactinaemia or thyroidal disorders or Cushing syndrome
Interventions 1. Myo‐inositol 4000 mg plus folic acid 400ug: 1 tablet per day (n = 14)
2. Placebo (n = 15)
Treatment was for 2 months prior to the IVF cycle and the trial ran for 4 months
Outcomes Number of retrieved oocytes
Ratio of follicles to retrieved oocytes
Fertilisation rate
Oocyte quality
Amount of FSH units used
Days of stimulation
Notes Conducted in Germany, study dates not reported
Has an author who was an employee of a pharmaceutical company
Funding source not reported
Contact details; Pedro‐Antonio Regidor (pedro‐antonio.regidor@exeltis.com) email sent on 13th October 2016 asking whether the placebo group received folic acid, methods of randomisation, allocation concealment, clinical pregnancy, live birth data and the length of the trial. Author replied 17th October 2016, no outcomes yet "but this is ongoing"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The method of randomization was a manual one. After fulfilling the including criteria the patients were allocated to the previously defined randomisation list"
Allocation concealment (selection bias) Unclear risk Unknown
Blinding (performance bias and detection bias) All outcomes Unclear risk Single‐blinded. "The biologist which carried out the fertilization was the blinded person. He did not know if the women were treated with myo‐Inositol or not" (placebo used)
Incomplete outcome data (attrition bias) All outcomes Low risk All randomised women were analysed
Selective reporting (reporting bias) Low risk No apparent reporting bias
Other bias Low risk No other bias found