Agrawal 2012

Methods	Prospective randomised trial
Participants	Women attending a teaching hospital fertility clinic undergoing ovulation induction for timed intercourse (N = 58). Mean age 32.2 years (range 19 to 40) Inclusion criteria: anovulatory infertility, at least 12 months of unexplained infertility, PCOS, hypothyroidism or minimal endometriosis Exclusion criteria: women whose partners had semen abnormalities and those who had been on multivitamins (except folate) 6 weeks before recruitment Women with tubal disease, moderate and severe endometriosis, medical disorders or haemoglobinopathies; smokers, those with excessive alcohol intake or BMI < 19 or > 34 kg/m2
Interventions	1. Multiple micronutrients (MMN): (n = 30) 1 tablet a day until completion of study (3 treatment cycles). Women who became pregnant could continue if they wished. These micronutrients consist of thiamine, riboflavin, niacin B3, vitamins B6 and B12, folate, vitamins C, A and D, calcium, phosphorus, magnesium, sodium, potassium, chloride, iron, zinc, copper, selenium, iodine, vitamin E, vitamin K, L‐arginine, inositol, N‐acetyl‐cysteine, biotin, pantothenic acid Mean age = 32.2 ± 0.65 2. Folic acid (n = 28): 1 tablet a day. Mean age = 32.5 ± 0.83 Women underwent ovulation induction with clomiphene citrate or human menopausal gonadotropin approximately 4 weeks after starting MMN or folic acid and continued until end of study, which was 3 cycles even if pregnancy was attained.
Outcomes	Clinical pregnancy Ongoing pregnancy Miscarriage Ectopic pregnancy
Notes	2 women did not complete the study－1 from each group. Reasons given: 1 woman in the control group stopped because she wanted to take the micronutrients, and 1 in the treatment group stopped because of nausea Trial is self‐funded. Author stated in an email received 13th February that the trial was not funded. Recruited between Febuary and August 2009 Location: London UK Informed consent Ethical approval Sample size power calculation performed ITT performed Emailed author 12th January 2012about whether the women had IUI or timed intercourse. Author replied on 7th February 2012 saying that all women underwent timed intercourse, not IUI. This email also gave adverse event data (miscarriage and ectopic pregnancy data) for the first cycle. Dr Agrawal is also currently recruiting for a new trial. Emailed author on 9th August 2012 asking about any live birth data. Author replied saying that live birth data were unavailable.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Third party randomization ... was carried out through the research and development department of the University College London and the Royal Free Hospitals using stratification..." "Participants were randomly allocated". Email sent 12th January 2012 asking for methods of randomisation. Author replied 13th February 2012 saying, "the subjects were randomised into 2 groups through computer randomisation".
Allocation concealment (selection bias)	Low risk	"Third party randomisation and allocation concealment was carried out through the research and development department of the University College London and the Royal Free Hospitals using stratification and numbered envelopes".
Blinding (performance bias and detection bias) All outcomes	Low risk	"Women, caregivers and investigators were blinded to the treatment allocation".
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT was performed and explanations given for the 2 dropouts (1 from each group)
Selective reporting (reporting bias)	Low risk	Outcomes stated in the text are reported.
Other bias	Low risk	No other bias found