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. 2017 Jul 28;2017(7):CD007807. doi: 10.1002/14651858.CD007807.pub3
Methods Randomised controlled trial
Participants Women with a diagnosis of unexplained infertility undergoing ovulation induction and IUI (n = 107)
Inclusion criteria: no ovulatory problems, normal hysterosalpingography and laparoscopy. Normal semen sample
Exclusion criteria: endometriosis, hypertension, diabetes, uterine myoma, ovarian cyst, excessive alcohol, caffeine, chronic illness and smoking
Interventions 1. Vitamin E: 400 IU: one tablet per day from 3rd to 5th day of the menstrual cycle until the hCG injection. (n = 53)
2. No treatment (n = 50)
4 women were lost to follow‐up as a result of incorrect dose consumption (n = 3) and cycle cancellation (n = 1). ITT not used in the trial
Outcomes Primary outcome: ongoing pregnancy rate
Secondary outcomes: biochemical and clinical pregnancy rate, number of follicles, endometrium thickness, implantation rate
Notes Study was conducted between June 2011 and December 2011 in Turkey
Sample size calculated
Ethics approved and written consent obtained
Funding not reported, but authors say they have no conflict of interest
Emailed author 9th August 2012 regarding the number of women lost from treatment and/or control group. Data added. Will perform sensitivity analysis for quality if we do not hear back from the author regarding ITT. No reply
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly assigned according to a randomisation table
Allocation concealment (selection bias) Unclear risk No mention of allocation concealment
Blinding (performance bias and detection bias) All outcomes High risk Not blinded as the control was no treatment
Incomplete outcome data (attrition bias) All outcomes High risk Reasons and numbers for attrition were given but unclear whether from treatment or control groups. ITT not used
Selective reporting (reporting bias) Low risk Nil known
Other bias Low risk No other bias found