to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
255
CHA Bundang Medical Center, CHA University
Gyeonggi-do, South Korea
CHA Gangnam Medical Center
Seoul, South Korea
Number of oocytes retrieved
Time frame: about 10 days after randomization
Proportion of subjects with LH (luteinizing hormone) rise > 10 mIU/mL
Time frame: about 8~9 days after randomization (visit 4)
Oocyte quality
Time frame: Day of oocyte retrieval (about 10 days after randomization)
Total administration dosage (IU) of Follitrope® PFS
Time frame: During 8~9 days after randomization (until administration hCG)
Total administration duration (day) of Follitrope® PFS
Time frame: During 8~9 days after randomization (until administration hCG)
Total administration dosage (mL) of Ganilever PFS or Orgalutran®
Time frame: From 4~5 days after randomization to 8~9 days after randomization
Total administration duration (day) of Ganilever PFS or Orgalutran®
Time frame: From 4~5 days after randomization to 8~9 days after randomization
Fertilization rate (%)
Time frame: Day of oocyte retrieval (about 10 days after randomization)
Implantation rate (%)
Time frame: About 4~5 weeks after Embryo transfer
Chemical pregnancy (%)
Time frame: About 2 weeks after oocyte retrieval
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Clinical pregnancy (%)
Time frame: About 4~5 weeks after Embryo transfer
Ongoing pregnancy (%)
Time frame: About 10~11 weeks after oocyte retrieval