This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China
This is a Phase 3, multicenter, blinded, randomized, controlled, parallel, comparative study for the evaluation of safety and efficacy of Recombinant human follicle-stimulating hormone injection (Follitrope) compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
451
Follitrope PFS
Gonal-f pen
Hangzhou Yuyuan Bioscience Technology Co.,Ltd
Hangzhou, Zhejiang, China
The total number of oocytes retrieved
The total number of oocytes retrieved
Time frame: 15 days after using FSH
Total dose and duration of FSH administration
Total dose and duration of FSH administration
Time frame: Throughout the study completion (e.g., 10 days)
No. of follicles with diameter equal or more than 14 mm on hGH injection day
No. of follicles with diameter equal or more than 14 mm on hGH injection day
Time frame: The day of hGH injection
No. of embryo transferred
No. of embryo transferred
Time frame: 3 days after the ovum pick-up
Clinical pregnancy rate
Clinical pregnancy rate by g-sac
Time frame: 5 weeks after the embryo transfer
On-going pregnancy rate
On-going pregnancy rate by fetal heart-beat
Time frame: 10 weeks after the embryo transfer
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