The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
354
The first Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Number of oocytes retrieved
36-38 hours after hCG administration, transvaginal ultrasound-guided aspiration was performed as required, and the number of oocytes was recorded.
Time frame: 36-38 hours after hCG administration
Total dose of r-hFSH administered
Time frame: From date of randomization up to 16 days
Number of days of r-hFSH stimulation
Time frame: From date of randomization up to 16 days
Serum estradiol concentration
Time frame: From date of randomization up to 16 days
Endometrial thickness
Time frame: From date of randomization up to 16 days
Fertilization Rate of Oocytes
Time frame: Day 1 of IVF/ICSI
Rate of high-quality embryos
Time frame: 3 days after oocyte retrieval
Implantation rate
Time frame: five to six weeks after oocyte retrieval
clinical pregnancy rate
Time frame: 35 ± 4 days after embryo transfer
Ongoing pregnancy rate
Time frame: Ten weeks after embryo transfer
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