Marci 2005.
| Methods | RCT, single‐centre, open‐label, parallel design | |
| Participants | 60 infertile women (poor responders) undergoing IVF/ICSI Inclusion criteria: estradiol concentrations < 600 pg/ml concentration on the day of hCG administration and a poor response (number of oocytes retrieved < 3) after a previous standard long protocol using analogues for down‐regulation and recombinant gonadotrophin at a dose of 225 IU for stimulation (rFSH, Gonal‐F) |
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| Interventions |
GnRH antagonist (n = 30): 375 IU rFSH (Gonal‐F) from cycle day 2 + GnRH antagonist cetrorelix 0.25 mg per day was then administered from when the two lead follicles had reached 14 mm diameter, irrespective of the day of the cycle until the day of hCG injection. (Flexible) GnRH agonist (n = 30): by analogues from day 23 of the cycle (Enantone 3.75 mg) + 375 IU daily , SC, rFSH, (Gonal‐F) from day 3 of the next cycle at a dose of 375 IU. In group B (n = 30), ovarian stimulation started at day 2 with rFSH at a dose of 375 IU (Gonal‐F) Oocyte maturation triggering: hCG (Profasi; Serono) 10,000 IU was administered IM 24 hrs after the last rFSH injection when at least two follicles had reached a diameter of 17 mm Oocyte retrieval: 36 hrs after hCG administration followed by IVF/ICSI Embryo transfers: were performed 48 hrs after oocyte retrieval Luteal phase: 2 × 200 mg/day of micronised vaginal progesterone (Prometrium) Follow up: serum hCG concentrations were measured 14 days after embryo transfer. Clinical pregnancies were confirmed 28 ‐ 35 days after embryo transfer by the presence of a gestational sac under ultrasound |
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| Outcomes | Age (years) Initiated cycles Stopped cycles Cycles with oocyte retrieval Stimulation duration (days) Number of ampoules Follicles > 15 mm Oocytes retrieved Oocytes fertilised Cycles with transfers Embryos transferred Endometrial thickness (mm) Clinical pregnancies |
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| Notes | Number of participants at randomisation: 60 (cetrorelix: 30/ enantone: 30) Number of participants at stimulation: 60 (cetrorelix: 30/ enantone: 30) Number of participants at OPU: 55 (cetrorelix: 29/ enantone: 26) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Reported as a randomised trial without any further details |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) All outcomes | High risk | Not blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcomes data |
| 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 | The study appears to be free from other sources of bias |