Vuong 2015.
Methods | Prospective, randomized trial.
Randomisation: by means of a computer programme.
Power analysis: 109 patients in each group would be required. Study period: 1 October 2012 to 30 June 2014. Sample size: 240 patients. Conflict of interests: No conflicts of interest. |
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Participants | All patients undergoing routine assisted cycles during the trial period were invited to participate. Age: ≥ 35 years. FSH: not stated. Exclusion criteria: participation in another interventional clinical trial, had PCOS, were WHO group 1, had uterine abnormalities such as uterine bicornuate, uterine cavity adhesion, and/or had endocrine disorders such as hyperprolactinaemia and thyroid disorders. Baseline characteristics to compare: age, number of treatment cycles, BMI, AMH, AFC, Cycles with reduced ovarian reserve. |
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Interventions | Ovarian stimulation was performed by using a GnRH antagonist protocol; rFSH was administered on day 2 or day 3 of the menstrual cycle. The first rFSH dose was individualised for each patient based on the following criteria: AFC ≤ 6, dose 300 IU/day; AFC7‐15, dose 225 IU/day; and AFC ≥ 16, dose 150 IU/day. Standard treatment: continued to receive rFSH. Experimental treatment: rLH was supplemented from day 6, 150/75 IU/day. |
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Outcomes | Primary endpoint: live birth rate. Secondary endpoints: clinical pregnancy rate, embryo implantation rate, miscarriage rate, duration of stimulation, total number of rFSH units used, estradiol concentrations on the hCG‐administered day, endometrial thickness on the hCG‐administered day, premature LH surge rate (>10 IU/l), number of oocytes retrieved, number of embryos, number of good embryos, number of patients with a premature rise in progesterone (>1.5 ng/ml) on the day of hCG administration, ovarian hyperstimulation syndrome, cycle cancellation due to poor response. |
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Notes | Funding: This study was supported by the Research Center for Genetics and Reproductive Health, School of Medicine, Vietnam National University HCMC. The authors state that they have no financial or commercial conflicts of interest. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence. |
Allocation concealment (selection bias) | Low risk | Allocation was concealed in sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Non‐blinding is not likely to affect the outcomes of interest as they are objectively assessed. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Non‐blinding of outcome assessment is not likely to affect outcomes of interest as they are objectively assessed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Numbers of women analyzed at the end of study were the same as those randomised at the beginning). |
Selective reporting (reporting bias) | Low risk | Outcome measures were specified in the methods section. |
Other bias | Low risk | Baseline demographic characteristics similar between the two treatment groups. |