DK001 | ITT | PP | ||
GM‐CSF | CONTROL | GM‐CSF | CONTROL | |
#Patients randomized | 654 | 678 | ||
#Transfer cycles | 587 | 605 | 564 | 585 |
#Embryos transferred | 874 | 913 | 838 | 882 |
Embryos transferred (mean) | 1.49 | 1.51 | 1.49 | 1.51 |
#Ongoing implantation w.7 | 204 | 181 | 197 | 176 |
Ongoing implantation w.7 (%) | 23.3+/‐1.4 | 19.8+/‐1.3 | 23.5+/‐1.5 | 20.0+/‐1.3 |
#Ongoing implantation w.12 | 199 | 170 | 193 | 165 |
Ongoing implantation w.12 (%) | 22.8+/‐1.4 | 18.6+/‐1.3 | 23.0+/‐1.5 | 18.7+/‐1.3 |
#Clinical Pregnancies w.7 | 189 | 175 | 183 | 171 |
Clinical Pregnancy rate w.7 (%) | 32.2 | 28.9 | 32.4 | 29.2 |
#Ongoing clinical pregnancies w.7 | 173 | 159 | 167 | 155 |
Ongoing clinical pregnancy rate w.7 (%) | 29.5+/‐1.9 | 26.3+/‐1.8 | 29.6+/‐1.9 | 26.5+/‐1.8 |
#Clinical pregnancies w.12 | 171 | 155 | 166 | 151 |
Clinical Pregnancy rate w.12 (%) | 29.1 | 25.6 | 29.4 | 25.8 |
#Ongoing clinical pregnancies w.12 | 170 | 149 | 165 | 145 |
Ongoing clinical pregnancy rate w.12 (%) | 29.0+/‐1.9 | 24.6+/‐1.8 | 29.3+/‐1.9 | 24.8+/‐1.8 |
#live birth | 168 | 145 | 163 | 141 |
Live birth rate (%) | 28.6+/‐1.9 | 24.0+/‐1.7 | 28.9+/‐1.9 | 24.1+/‐1.8 |
#Stillborn children | 0 | 0 | 0 | 0 |
#Liveborn children | 200 | 169 | 194 | 164 |
#Singletons | 137 | 121 | 133 | 118 |
#Twins | 60 | 48 | 58 | 46 |
Dizygotic | 54 | 42 | 52 | 40 |
Monozygotic | 6 | 6 | 6 | 6 |
#Triplets* | 3 | 0 | 3 | 0 |
#Pos. hCG | 222 | 226 | 214 | 218 |
#Early pregnancy loss (</=w.12) | 52 | 77 | 49 | 73 |
#Biochemical | 31 | 48 | 29 | 44 |
#Ectopic | 4 | 2 | 4 | 2 |
#Miscarriage (loss w.7‐12) | 17 | 27 | 16 | 27 |
#Miscarriage observed week 7 | 14 | 17 | 14 | 17 |
#Miscarriage observied week 12 | 3 | 10 | 2 | 10 |
#Late pregnancy loss (>w.12) Miscarriage/elective termination due to malformations |
2 | 4 | 2 | 4 |