Humaidan 2010.
Methods | Randomised, controlled, 3‐centre study | |
Participants | 302 normo‐gonadotrophic IVF/ICSI participants, 25 to 40 years of age, BMI 18 to 30 kg/m2, basal FSH < 12 IU/L, menstrual cycle 25 to 34 days, both ovaries present, absence of uterine abnormalities. Each participant contributed with only 1 cycle Baseline characteristics: 31.5 vs 30.9 years of age, BMI 23.8 vs 23.5, basal FSH 6.7 vs 6.7 |
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Interventions |
Ovarian stimulation: adjustable dose of 150 to 200 IU rFSH + 0.25 mg ganirelix Intervention: 0.5 mg buserelin SC plus 1500 IU HCG IM 35 hours after triggering of ovulation vs 10,000 IU HCG Luteal phase support: 90 mg/d progesterone vaginal plus 4 mg/d oestradiol, beginning on the day after OPU and continuing until the day of the pregnancy test |
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Outcomes |
Primary outcomes: reduction in high early pregnancy loss rate Secondary outcomes: MII oocytes retrieved, OHSS incidence, ongoing pregnancy rate |
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Notes | A total of 305 participants were included in the study, but 3 were not randomly assigned because of inadequate ovarian response Not stated 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 |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes. No further details were reported |
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 | Low risk | No other potential bias was identified |