To explore the optimal effective daily dose of BG2109 to suppress premature luteinizing hormone (LH) surge during COH in female subjects undergoing ART procedures.
This study is a randomized, double-blind, open for active comparator, parallel, multi-center phase II dose-finding clinical study to explore the efficacy, safety and tolerability of different doses of BG2109 compared with Cetrorelix during Controlled Ovarian Hyperstimulation (COH) in Chinese female subjects undergoing Assisted Reproductive Technology (ART) procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
oral administration once daily
0.25 mg, Subcutaneous injection once daily.
Site No5
Changsha, China
Site No7
Guangzhou, China
Site No9
Haikou, China
Site No4
Hangzhou, China
Suppression rate of premature LH surge from the treatment of investigational medicinal products(IMP) until the day of human chorionic gonadotropin(hCG) injection
LH ≥ 10 IU/L
Time frame: Through the whole period of administration of IMP,about 5-10 days
Ongoing pregnancy rate
ongoing pregnancy is defined as at least embryo with heartbeat at 10 weeks post-embryo transfer
Time frame: At 10 weeks post-embryo transfer
The number of oocytes obtained on the day of oocyte retrieval
Time frame: During the surgery of the oocyte retrieval
Clinical pregnancy rate
clinical pregnancy is defined as the presence of at least one gestational sac in or outside the uterus during 30-37 days after embryo transfer
Time frame: On 30-37 days after embryo transfer
Adverse drug events
Time frame: Through study completion, around 45 weeks.
Pharmacokinetics(PK) endpoints
Plasma concentration of BG2109
Time frame: On the morning of the Second and Third day of BG2109 administration, and the day of hCG injection(about 5-10days after BG2109 administration)
Pharmacodynamics(PD) endpoints
estradiol(E2), luteinizing hormone (LH) and progesterone (P) concentrations at each time point
Time frame: 30 minutes before the administration of BG2109 every morning through the whole period of IMP administration,about 5-10 days
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Site No8
Hohhot, China
Site No6
Linyi, China
Site No10
Shenyang, China
Site No11
Tianjin, China
Site No3
Wuhan, China
Site No2
Zhengzhou, China