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 |
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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 |
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Outcomes | Number of retrieved oocytes Ratio of follicles to retrieved oocytes Fertilisation rate Oocyte quality Amount of FSH units used Days of stimulation |
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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" |
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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 |