The aim of this randomized, open-label, active-controlled, parallel-group, multicenter, phase IV study is to assess the efficacy and safety of Fang Le Shu versus Guo Na Fen used for controlled ovarian stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
rFSH 150 IU, 225 IU, 300 IU per syringe
rFSH 450 IU per pen
The first affiliated hospital of Zhengzhou University
Zhengzhou, China
RECRUITINGNumber of oocytes retrieved
Time frame: 36 ± 3 hours after HGC trigger
High quality embryo rate
Time frame: 3 days after oocyte retrieval
Biochemical pregnancy rate
Time frame: 14 days after embryo transfer
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: 10 weeks after embryo transfer
Miscarriage rate
Time frame: 28 weeks of gestation
Live birth rate
Time frame: 40 weeks of gestation
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