Van Der Auwera 1994.
Methods | Single‐centre parallel RCT | |
Participants | 209 women Baseline comparison: similar Infertility cause: endometriosis, tubal, male factor, mixed or unexplained Inclusion criteria: women with functioning ovaries who had embryos originating from IVF using their own oocytes Exclusion criteria: none Number of transferred embryos: in clomiphene group 1.8 ± 0.1, in HMG group 2.0 ± 0.1 |
|
Interventions |
Clomiphene plus HMG (107 women) Oral clomiphene 100 mg started in days 2‐6 and HMG 150 μg/d IM from day 6 HMG (102 women) HMG 150 μg/d IM from day 2 In both groups from day 7 onwards, OI was done on individual basis Monitoring: by US and plasma E2 measurements Once leading follicle was ≥ 18 mm and E2 > 500 pg/mL, ovulation was induced using HCG 10,000 IU Day of HCG administration: in clomiphene plus HMG group 11.7 ± 0.2, in HMG group 10.8 ± 0.2 (P < 0.01) FET was performed 64 h post HCG administration or 48 h after LH surge. Luteal phase support: HCG 1500 IU IM on days 4, 7 and 10 post FET and progesterone vaginal suppositories 100 mg/d |
|
Outcomes | Live birth rate per woman Miscarriage rate per woman Multiple pregnancy rate per woman |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Procedure used in random sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | No report on allocation concealment |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported whether participants or personnel (or both) were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information on attrition although tabular data were presented in a way that suggested possible inclusion of all randomized women in data analysis |
Selective reporting (reporting bias) | Unclear risk | Data reported on outcomes prespecified in the methods section |
Other bias | Unclear risk | Both groups were similar with respect to participants' characteristics, and number and quality of embryos transferred but HCG was administered on different days, although this was said not to have affected the outcome of the trial |