Humaidan 2005.
| Methods | Randomised, controlled, open‐label, 2‐centre study | |
| Participants | 122 normo‐gonadotrophic women for IVF or ICSI. 25 to 40 years of age, baseline FSH and LH 12 IU/L, menstrual cycles between 25 and 34 days, BMI 18 to 30 kg/m2, both ovaries present, absence of uterine abnormalities. Each participant contributed with 1 cycle only Baseline characteristics: 33.4 vs 32.3 years of age, BMI 23.6 vs 23.5, FSH 6.8 vs 6.7 |
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| Interventions |
Ovarian stimulation: adjusted dose of 150 or 200 IU rFSH on cd 2 + 0.25 mg ganirelix Intervention: 0.5 mg buserelin SC vs 10,000 IU HCG SC Number of embryos transferred: Maximum of 2 embryos were transferred. Mean number of embryos transferred: mean and range: 1.71 (1 to 2) vs 1.64 (1 to 2) Luteal phase support: 90 mg/d progesterone vaginally plus oestradiol 4 mg/d per os, commencing from the day following oocyte retrieval and continuing until the day of the pregnancy test |
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| Outcomes |
Primary outcomes: positive HCG per ET. Clinical pregnancy. Early pregnancy loss Secondary outcomes: rate of embryo transfer (ET), numbers of embryos transferred, implantation rate, oocytes retrieved, MII oocytes, pronuclear oocytes, embryos (%); E2, FSH and LH levels on sd1, day 6 and ovulation induction day; progesterone on ovulation induction day |
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| Notes | Terminated because of differences in clinical outcomes between groups Embryo transfer was cancelled in 7 patients in the GnRH agonist group and in 10 patients in the HCG group as the result of total fertilisation failure or poor embryo development Commercial funding: unclear whether investigators received commercial funding |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
| Allocation concealment (selection bias) | Low risk | By a study nurse; using computer‐generated random numbers in sealed, unlabelled envelopes, each containing a unique study number |
| Blinding (performance bias and detection bias) FOR OHSS OUTCOME | High risk | Participants, those administering interventions and those assessing outcomes were not blinded to group assignment. Risk applies to assessment of OHSS |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No outcome data were missing |
| Selective reporting (reporting bias) | Low risk | Study protocol is not available, but it is clear that published reports include most expected outcomes |
| Other bias | High risk | Terminated early because of differences in clinical outcomes between groups |