Sbracia 2009.
| Methods | RCT, single‐centre | |
| Participants | 564 low responders, undergoing their first IVF cycle were eligible for the study Inclusion criteria: age 40 years or older and no previous IVF cycle Exclusion criteria: PCOS, FSH > 10 IU/ mL, a previous IVF cycle, and age 45 years or older Baseline characteristics: maternal age, years 42.3 1.4 vs 42.1 1.5, BMI 25.1 2.6 vs 24.8 2.4, basal FSH levels, IU/L 7.0 2.5 vs 6.9 2.4 |
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| Interventions |
Group A (n= 285): 300 IU/day r‐hFSH (Gonal‐F) + 0.25 GnRH antagonist cetrorelix (Cetrotide) when the leading follicle ≃ 14 mm or the E2 plasma levels were 600 pg/mL (flexible multiple‐dose protocol) Group C (n= 285): buserelin 0.4 mg/day long GnRH agonist + 225 IU/day rhFSH (Gonal‐F) (GnRH agonist protocol) Oocyte maturation triggering: 10,000 IU of IM hCG when plasma E2 between 800 and 3500 pg/mL and at least three follicles > 16 mm in mean diameter Oocyte retrieval: 36 hours later, followed by ICSI Maximum number of embryos transferred: 3 Luteal phase support: 50 mg daily of P (Prontogest) IM from the day of replacement Follow up: pregnancies were confirmed by a rising titre of serum b‐hCG 12 days after ET and ultrasound demonstration of the gestation sac four weeks after the transfer |
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| Outcomes | Primary outcomes: clinical pregnancy rate per cycle started and per transfer Secondary outcomes: days of stimulation, E2 at the day of hCG, amount of FSH administered, number of oocytes yielded, number of embryos transferred, implantation rate, and abortion rate | |
| Notes | Drop out: four women in the cetrorelix group and two in the control group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation number sequence at the time that their cycle was scheduled |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No missing outcome data, however, LBR, OPR were not addressed by the study |
| Selective reporting (reporting bias) | Low risk | The study protocol was not available, but it is clear that the published reports included most expected outcomes |
| Other bias | Low risk | Groups balanced at baseline |