This is a multi-centre, single-arm, observational trial to assess the safety and efficacy of corifollitropin alfa N02 Injection in elderly Chinese women undergoing ART, and then to explore the compliance and satisfaction during COS treatment.
Study Type
OBSERVATIONAL
Enrollment
200
Data will be collected without interfering with routine clinical care.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From signing the ICF to the birth of the newborn
Incidence of early-onset ovarian hyperstimulation syndrome (OHSS)
Time frame: Up to 9 days after triggering of final follicular maturation
Incidence of moderate to severe OHSS
Time frame: Up to 10-11 weeks after transfer
fetal/newborn birth defects
Time frame: Up to 15 months
1-year cumulative clinical pregnancy rate per initiated stimulation cycles
Time frame: 4 to 6 weeks after last frozen embryo transfer
1-year cumulative ongoing pregnancy rate per initiated stimulation cycles
Time frame: 9 to 11 weeks after last frozen embryo transfer
1-year cumulative live birth rate per initiated stimulation cycles
Time frame: more than 40 weeks after last frozen embryo transfer
β-hCG/hCG positive rate per initiated stimulation cycles with fresh embryo transfer
Time frame: 4 weeks after fresh embryo transfer
Clinical pregnancy rate per initiated stimulation cycles with fresh embryo transfer
Time frame: 4 to 6 weeks after fresh embryo transfer
Ongoing pregnancy rate per initiated stimulation cycles with fresh embryo transfer
Time frame: 9 to 11 weeks after fresh embryo transfer
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Live birth rate per initiated stimulation cycles with fresh embryo transfer
Time frame: more than 40 weeks after fresh embryo transfer
β-hCG/hCG positive rate per initiated stimulation cycles with first embryo transfer cycle
Time frame: 4 weeks after first embryo transfer
Clinical pregnancy rate per initiated stimulation cycles with first embryo transfer cycle
Time frame: 4 to 6 weeks after first embryo transfer
Ongoing pregnancy rate per initiated stimulation cycles with first embryo transfer cycle
Time frame: 9 to 11 weeks after first embryo transfer
Live birth rate per initiated stimulation cycles with first embryo transfer cycle
Time frame: more than 40 weeks after first embryo transfer
Pregnancy loss rate
Time frame: Up to 38 weeks after transfer
Number of oocytes retrieved
Time frame: Up to 22 days
Estrogen (E₂) and progesterone (P) levels during controlled ovarian stimulation (COS)
Time frame: Up to 22 days
Follicular development status
Time frame: Up to 22 days
Metaphase II (MII) oocyte rate [evaluated only in intracytoplasmic sperm injection (ICSI) cycles]
Time frame: Up to 22 days
Fertilization rate Implantation rate
Time frame: Day 3 after oocyte retrieval
Implantation rate
Time frame: Up to 28 days
High-quality embryo rate
Time frame: Day 3 after oocyte retrieval
Usable blastocyst formation rate
Time frame: Day 5 after oocyte retrieval