Peeraer 2015.
Methods | Single‐centre, 2‐arm parallel, open‐label RCT | |
Participants | 472 women undergoing FET Inclusion criteria: women undergoing FET were eligible for the study when they had a regular cycle (between 21 and 35 days) and were aged 21‐45 years Exclusion criterion: FET after PGD Participants were similar in demographic and infertility characteristics at baseline |
|
Interventions |
Natural cycle (235 women) Women underwent a first pelvic US and blood analysis around day 10‐day 12 of the menstrual cycle. HCG administered when the leading follicle had a mean diameter of ≥ 17 mm and endometrial thickness ≥ 7 mm with serum estradiol levels preferably 150 ng/L. HMG cycle (237 women) Women started SC injections of gonadotrophins (follitropin plus LH) on day 2 of the menstrual cycle. Starting dose of gonadotrophins (37 or 75 IU) determined by the treating clinician, based on woman's age, BMI, basal serum FSH (days 2‐5) and (if applicable) response to previous ovarian stimulation. On day 6 or 7 of the menstrual cycle, a first US and serum hormonal analysis (E2, progesterone, LH, FSH) performed. Based on these results, dose of gonadotrophins could be adjusted if needed. In both natural cycle FET and HMG FET cycle groups, the follicular response was monitored by regular vaginal US and serum hormonal analysis. ET was performed the same way in both groups. |
|
Outcomes | Live birth per ET Ongoing pregnancy per ET Clinical pregnancy per ET Endometrial thickness |
|
Notes | Outcome data reported as per 'embryo transfer cycle' (dichotomous data) or not clearly stated and there were multiple transfers per woman | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Process of randomization not sufficiently explained. |
Allocation concealment (selection bias) | Low risk | Allocations concealed in opaque sealed envelope. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as an open‐label trial, thus both participants and personnel were aware of the treatment protocols. However, non‐blinding of outcome assessors may not have affected some of the outcome measures as they were objectively assessed. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Analysis was based on per cycle transferred. |
Selective reporting (reporting bias) | Low risk | Outcome measures were prespecified in the methods section. |
Other bias | Low risk | Participants similar in demographic and infertility characteristics at baseline. |