Fauser 2002.
| Methods | Randomised, controlled, open‐label, 3‐arm, 6‐international centre study | |
| Participants | 57 women for IVF/ICSI. 18 to 39 years of age, regular menstrual cycle (24 to 35 days) and BMI 18 to 29 kg/m2. Baseline characteristics were comparable between the 3 treatment groups: mean age 30.4 years, height 1.67, BMI 23.3; 98% were Caucasian | |
| Interventions |
Ovarian stimulation: adjustable dose of 150 to 225 IU rFSH, SC on cd 2 to 3 for the first 5 days + 0.25 mg ganirelix on day 6 of FSH stimulation Intervention: 0.2 mg triptorelin vs 0.5 mg leuprorelin vs 10,000 IU HCG Number of embryos transferred: GnRH agonist group vs HCG group: No more than 3 embryos were transferred Luteal phase support: progestin 50 mg daily, from the day of embryo transfer (ET) for at least 2 weeks or until menses |
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| Outcomes |
Primary outcomes: FSH, LH, E2, HCG and P in the luteal phase Secondary outcomes: FSH consumption (IU); duration of FSH treatment (days); duration of ganirelix treatment (days); number of oocytes/participant on day of HCG or GnRH agonist proportion of metaphase II oocytes; fertilisation rate; number of embryos obtained/participant; embryo quality; implantation rate; ongoing pregnancy rate |
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| Notes | Sample calculation not performed 57 of 200 participants; only 47 were randomly assigned. Eight participants were not randomly assigned because ovarian response to stimulation was not sufficient. Two participants were not randomly assigned because of high response. One participant in the hCG group did not undergo ET because of fertilisation failure. Duration of fertility was not stated, no data on live birth rate and on OHSS incidence and multiple pregnancy rates were provided Commercial funding: supported by NV Organon |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Interactive telephone randomisation system that stratified for age, primary or secondary infertility and number of follicles. Participants were randomly assigned in a ratio of 1:1:1 |
| Allocation concealment (selection bias) | Unclear risk | Adequate |
| Blinding (performance bias and detection bias) FOR OHSS OUTCOME | High risk | Outcome assessors and participants were not blind to the intervention. Risk applies to assessment of OHSS |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No outcome data were missing |
| Selective reporting (reporting bias) | Unclear risk | Study protocol is not available. Live birth rate was not reported |
| Other bias | Low risk | No other potential bias was identified |