Methods | Randomised controlled trial | |
Participants | Infertile women with PCOS undergoing ovulation induction for ICSI (n = 60) Mean age (years) treatment: 36.2 ± 2.4; non‐treatment 35.4 ± 2.5 Inclusion criteria: women aged < 40 years with PCOS, indicated by oligomenorrhoea (6 or fewer menstrual cycles during a period of 1 year), hyperandrogenism (hirsutism, acne or alopecia) or hyperandrogenaemia (elevated levels of total or free T) and typical features of ovaries on ultrasound scan. All women had been treated at the IVF clinic for > 12 months. Exclusion criteria: other medical conditions causing ovulatory disorders such as hyperinsulinaemia, hyperprolactinaemia, androgen excess such as adrenal hyperplasia or Cushing's syndrome Duration of infertility (months) treatment: 46.1 ± 18.5, non‐treatment: 37.7 ± 9.6 |
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Interventions | 1. Myo‐inositol 2 g + folic acid 400 µg (Inofolic®): 2 tablets a day (n = 30) 2. Folic acid 400 µg (n = 30) Duration: for 1 cycle of ICSI. Treatment starting on the day of GnRH administration |
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Outcomes | Number of mature oocytes retrieved Embryo quality Pregnancy Implantation rates Total number of days of FSH stimulation Total dose of gonadotropin administered Oestrogen levels Fertilisation rate Number of retrieved oocytes Embryo cleavage rate Live births Miscarriage rates Cancellation rate Incidence of moderate or severe ovarian hyperstimulation syndrome |
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Notes | The Institutional Review Board approved the protocol, and all participants gave written informed consent before entering into the trial Source of funding not stated Power calculation performed Authors contacted. Trial conducted in Italy, start date March 2004 (unknown end date) Authors could not supply live birth data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised according to "computerised allocation". Authors have since confirmed this |
Allocation concealment (selection bias) | Unclear risk | "Computerised allocation" |
Blinding (performance bias and detection bias) All outcomes | High risk | Authors confirmed in correspondence that participants and investigators were not blinded; however, outcome assessors and clinicians were blinded. Not a placebo control |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals or dropouts |
Selective reporting (reporting bias) | High risk | Data on live birth were not reported in the paper, even though it was listed as an outcome in the abstract of the paper |
Other bias | Low risk | No other bias found |