Controlled Ovarian Stimulation
Conditions
Brief summary
to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies
Interventions
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* An adult female between the ages of 20 and 39 at the time of screening * Patients whose mean menstrual cycle was between 25 and 35 days * Patients whose FSH (follicle stimulating hormone) concentration does not exceed 13 mIU / mL at screening * Patients diagnosed with infertility due to one or more of the following A. Trouble Factors B. Male Factors C. Unexplained D. Uterine factors * Patients with previous IVF experience less than 3 * Patient who signed the written consent after hearing the explanation of the purpose, method and effect of the clinical trial
Exclusion criteria
* If the sperm donor (spouse or non-spouse) is a severe male factor (Non obstructive azoospermia) * Patients who were diagnosed as PCOS (polycystic ovary syndrome) during screening * Patient with abnormal uterine bleeding during screening * Patients diagnosed with primary ovarian failure * Patients who has ovarian cysts that are not related to PCOS during screening * Patients with tubal hydrops * Patients with untreated non-reproductive endocrine disease * Patients with a deformity of the reproductive organs that can not be conceived, or fibroids of the uterus that can not be conceived (only for submucosal myoma) * Patients with less than 2 ovaries (0 or1) * Patients with ovarian, breast, uterus, hypothalamus, or pituitary malignancies * Patients with BMI \<18 or BMI\> 30 * Patients with an LH concentration of less than 1.2mIU / mL during screening * Poor ovarian responder by bologna criteria * Patients with moderate or severe renal impairment (creatinine clearance \<60 mL / min) or liver function impairment (ALT or AST,\> 5 times normal) * Patients who experienced Grade 4 or higher OHSS (ovarian hyperstimulation syndrome) before * Patients who are contraindicated for pregnancy * Patients being pregnant or lactating * Patients with hypersensitivity to IP * Patients who have participated in other medication-related clinical trials since enrollment in this study, or have participated in other clinical trials within 3 months (90 days) before enrolling in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved | about 10 days after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Oocyte quality | Day of oocyte retrieval (about 10 days after randomization) |
| Total administration dosage (IU) of Follitrope® PFS | During 8~9 days after randomization (until administration hCG) |
| Total administration duration (day) of Follitrope® PFS | During 8~9 days after randomization (until administration hCG) |
| Total administration dosage (mL) of Ganilever PFS or Orgalutran® | From 4~5 days after randomization to 8~9 days after randomization |
| Total administration duration (day) of Ganilever PFS or Orgalutran® | From 4~5 days after randomization to 8~9 days after randomization |
| Proportion of subjects with LH (luteinizing hormone) rise > 10 mIU/mL | about 8~9 days after randomization (visit 4) |
| Implantation rate (%) | About 4~5 weeks after Embryo transfer |
| Chemical pregnancy (%) | About 2 weeks after oocyte retrieval |
| Clinical pregnancy (%) | About 4~5 weeks after Embryo transfer |
| Ongoing pregnancy (%) | About 10~11 weeks after oocyte retrieval |
| Fertilization rate (%) | Day of oocyte retrieval (about 10 days after randomization) |
Countries
South Korea
Outcome results
None listed