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. 2017 Jul 28;2017(7):CD007807. doi: 10.1002/14651858.CD007807.pub3
Methods Randomised single‐centre controlled clinical trial
Participants Women undergoing IVF with sleep disturbances (n = 63) from 24 ‐ 38 years
Inclusion criteria: unexplained infertility, no ovulatory problems, normal hysterosalpingogram or laparoscopy and normal semen sample
Exclusion criteria: chronic drug usage, history of > 1 fertilisation failure, hypertension, diabetes, uterine myoma, ovarian cyst and smoking
Interventions 1. Melatonin 3 mg; 1 tablet a day, taken at 22:00 to 23:00 from 3rd to 5th day of the menstrual cycle until the hCG injection (n = 30)
2. No treatment (n = 30)
Outcomes Primary outcome: oocyte quality
Secondary outcomes: fertilisation failure rate, number of follicles, number of oocytes retrieved, number of Mll oocytes, fertilisation rate, number of embryos transferred, embryo quality, implantation rate and clinical pregnancy rate
Notes Trial held in Turkey
Ethics approved, written informed consent gained. Authors declare no conflicts of interest
Power calculation performed
Emailed author 9th August 2012 regarding which group or groups lost the 3 women. Data added. Tried to contact the author again regarding live birth data 5th February 2013 Author replied on 7th February 2013 , saying that the 3 dropouts were from the treatment group, and that no allocation concealment was performed and no live birth data were available because participants were mainly from rural sites
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned according to a randomisation table
Allocation concealment (selection bias) High risk No allocation concealment
Blinding (performance bias and detection bias) All outcomes High risk No blinding as control is no treatment
Incomplete outcome data (attrition bias) All outcomes Low risk Dropouts explained
Selective reporting (reporting bias) Low risk Outcomes reported
Other bias Low risk No other bias found