Table 2.
Secondary efficacy endpoints (per-protocol population).
| Secondary Endpoint | r-hFSH-BS n=45 |
original α r-hFSH n=41 |
Difference | p |
|---|---|---|---|---|
| Total r-hFSH dose (IU) - Mean (SD); Range | 2034 (439); 1200-3400 | 1965 (373); 1350-3000 | 69 | 0.431* |
| Mean r-hFSH dose (IU) - Mean (SD) Range | 230 (20); 169-283 | 225 (19); 169-273 | 5 | 0.277* |
| Duration of r-hFSH stimulation (days) - Mean (SD) Range | 8.8 (1.5); 6-13 | 8.7 (1.3); 6-11 | 0.1 | 0.708* |
| Total dose adaptation - % (n) | 37.8% (17) | 36.6% (15) | 1.2% | 0.909† |
| Dose increase - % (n) | 24.4% (11) | 14.6% (6) | 8.4% | 0.254† |
| Dose decrease- % (n) | 13.3% (6) | 22.0% (9) | -8.7% | 0.293† |
| Fertilization rate - % (n) | 69.2% (243/351) | 73.7% (252/342) | -4.5% | 0.100* |
| Number of fertilyzed oocytes - Mean (SD); Range | 5.4 (4.0); 0-16 | 6.2 (3.7); 0-15 | -0.8 | 0.375* |
| Good quality embryos (ESHRE) - Mean (SD) Range | 0.38 (0.7); 0-2 | 0.22 (0.7); 0-3 | 0.16 | 0.276* |
| Number of embryos/blastocysts transferred - Mean (SD), Range | 1.51 (0.7); 0-2 | 1.61 (0.7); 0-3 | -0.10 | 0.515* |
| Implantation rate - % (n) | 20.6% (14/68) | 15.2% (10/66) | 5.4% | 0.275* |
| Biochemical pregnancies - % (n) | 8.9% (4) | 12.2% (5) | -3.3% | 0.617† |
*
t Student
†
Cochran
FSH=follicle-stimulating hormone; SD=Standard Deviation; %=percentage; n=number