Babayof 2006.
Methods | Randomised, controlled, single‐centre study | |
Participants | 28 women with PCOS for IVF. Basic clinical characteristics: Both groups were similar in age: 30.1 vs 29.3, BMI 24.1 vs 27.1 and cause of infertility; 5.8 vs 5.3 and basal FSH (IU/L) 7.8 vs 4.3 | |
Interventions |
Ovarian stimulation: adjustable dose of 225 IU SC rFSH + 0.25 mg SC cetrotide Intervention: 0.2 mg decapeptyl vs 250 μg rHCG Number of embryos transferred: GnRH agonist group vs HCG group (mean: 2.3 ± 0.2 vs 2.2 ± 0.4) Luteal phase support: 50 mg/d of progesterone IM ± 4 mg/d E2 PO (if serum E2 concentration was below 200 pmol/L ± doubled dose of progesterone if serum progesterone concentration was below 40 nmol/L) |
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Outcomes |
Primary outcome: serum levels of inhibin A, VEGF, TNFa, E2 and progesterone and incidence of OHSS Secondary outcomes: ovarian size and pelvic fluid accumulation, live birth, ongoing, chemical, miscarriage, number of oocytes retrieved, number of MII oocytes, fertilisation rate and number of embryos transferred |
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Notes |
OHSS classification:Golan 1989 HCG group: 2 cases of ET were cancelled, and all embryos were frozen as the result of severe OHSS with accumulation of large amount of free fluid in the pelvis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation list |
Allocation concealment (selection bias) | Low risk | An independent nurse dispensed HCG or GnRH agonist according to a randomisation list |
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 |