The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
259
On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration.
a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 \<= 50 pg/ml (\<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG.
The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.
The hCG criterion is met the first day that 3 follicles \>= 17 mm are observed.
Time frame: At completion of ovarian stimulation; maximally after 18 days of recFSH administration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.