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.
Is pre-menopausal female aged ≥20 to <40 years.
Has regular menstrual cycles of ≥25 to ≤35 days.
Has Normal baseline serum FSH, LH, E2, P4.
Is able to voluntarily sign the informed consent form (ICF).
Has any known clinically significant major systemic disease, or endocrine or metabolic abnormalities with the exception of controlled thyroid function disease.
Has body mass index (BMI) of >30 kg/m2.
Has clinically significant abnormalities of the uterus, ovary, or appendix prior to the day of randomization
Has history of surgeries that may affect oocyte retrieval or pregnancy outcome, such as surgical resection of uterine mediastinum, fibroids, or cysts (however, patients who received polypectomy are allowed to enroll).
Parallel
Fang Le Shu (Follitrope)
DrugrFSH 150 IU, 225 IU, 300 IU per syringe
Guo Na Fen (Gonal-F)
DrugrFSH 450 IU per pen
Number of oocytes retrieved
High quality embryo rate
Biochemical pregnancy rate
Clinical pregnancy rate
Ongoing pregnancy rate
