Clinical trial NCT03051087: To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®
Official title: A Multicenter, Randomized, Treated-controlled, Parallel, Open Label Study to Compare and Evaluate the Efficacy and Safety of Ganilever PFS and Orgalutran® in Infertility Women for Assisted Reproductive Technologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Controlled Ovarian Stimulation
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2017-02-13
Enrollment: 255
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies


Eligibility criteria: 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

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: about 10 days after randomization
Secondary outcomes:
measure: Proportion of subjects with LH (luteinizing hormone) rise > 10 mIU/mL
timeFrame: about 8~9 days after randomization (visit 4)
measure: Oocyte quality
timeFrame: Day of oocyte retrieval (about 10 days after randomization)
measure: Total administration dosage (IU) of Follitrope® PFS
timeFrame: During 8~9 days after randomization (until administration hCG)
measure: Total administration duration (day) of Follitrope® PFS
timeFrame: During 8~9 days after randomization (until administration hCG)
measure: Total administration dosage (mL) of Ganilever PFS or Orgalutran®
timeFrame: From 4~5 days after randomization to 8~9 days after randomization
measure: Total administration duration (day) of Ganilever PFS or Orgalutran®
timeFrame: From 4~5 days after randomization to 8~9 days after randomization
measure: Fertilization rate (%)
timeFrame: Day of oocyte retrieval (about 10 days after randomization)
measure: Implantation rate (%)
timeFrame: About 4~5 weeks after Embryo transfer
measure: Chemical pregnancy (%)
timeFrame: About 2 weeks after oocyte retrieval
measure: Clinical pregnancy (%)
timeFrame: About 4~5 weeks after Embryo transfer
measure: Ongoing pregnancy (%)
timeFrame: About 10~11 weeks after oocyte retrieval
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center
Study officials:
References: