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 |