Methods | Randomised controlled trial | |
Participants | Women with PCOS having clomiphene citrate for ovulation induction (timed intercourse) (n = 200) | |
Interventions | 1. Combined antioxidant supplementation; vitacap which contains vitamin A (Palmitate) 5000 iu, vitamin B1 (thiamine mononitrate) 5 mg, vitamin B6 (pyridoxine HCL) 2 mg, vitamin B12 (cyanocobalamin 5 mg, vitamin C 75 mg, vitamin D3 (cholecalciferol) 400 iu, Vitamin E (d‐alpha tecopheryl acetate ) 15 mg, nicotinamide 45 mg, folic acid 1000 mcg, ferrous fumerate 50 mg, dibasic calcium phosphate 70 mg, copper sulphate 0.1 mg, manganese sulphate 0.01 mg, zinc sulphate 50 mg, potassium iodide 0.025 mg and magnesium oxide 0.5 mg: 1 vitacap a day (n = 100) 2. Placebo; containing folic acid and fersolate. 1 tablet a day (n = 100) Treatment given for 6 months |
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Outcomes | Live birth Clinical pregnancy Menstrual regularisation |
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Notes | Conducted in Nigeria, study dates not reported Conference abstract Funding source not reported kapanti2002@yahoo.co.uk, email sent 18th October 2016. Author replied 20th October 201 with live birth data. Emailed author re allocation concealment of odd and even envelopes 25th January 2017 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The women were randomized into two groups by picking one of the two closed envelops. within the envelop is written odd or even number. The odd number for intervention and even number for control. The selection of odd and even number for intervention and control group was done by toss of coin" |
Allocation concealment (selection bias) | Low risk | "The women were randomized into two groups by picking one of the two closed envelopes, within the envelope is written odd or even number". |
Blinding (performance bias and detection bias) All outcomes | Low risk | "The trial was single blinded. The patient did not know" a placebo was used |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts accounted for |
Selective reporting (reporting bias) | Low risk | Outcomes reported |
Other bias | Low risk | No other bias found |