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To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051087
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

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

Condition or disease Intervention/treatment Phase
Controlled Ovarian Stimulation Drug: Ganirelix acetate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ganilever (ganirelix acetate)
Prefilled syringe / 0.25mg/0.5mL
Drug: Ganirelix acetate
Active Comparator: Orgalutran (ganirelix acetate)
Prefilled syringe / 0.25mg/0.5mL
Drug: Ganirelix acetate



Primary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: about 10 days after randomization ]

Secondary Outcome Measures :
  1. Proportion of subjects with LH (luteinizing hormone) rise > 10 mIU/mL [ Time Frame: about 8~9 days after randomization (visit 4) ]
  2. Oocyte quality [ Time Frame: Day of oocyte retrieval (about 10 days after randomization) ]
  3. Total administration dosage (IU) of Follitrope® PFS [ Time Frame: During 8~9 days after randomization (until administration hCG) ]
  4. Total administration duration (day) of Follitrope® PFS [ Time Frame: During 8~9 days after randomization (until administration hCG) ]
  5. Total administration dosage (mL) of Ganilever PFS or Orgalutran® [ Time Frame: From 4~5 days after randomization to 8~9 days after randomization ]
  6. Total administration duration (day) of Ganilever PFS or Orgalutran® [ Time Frame: From 4~5 days after randomization to 8~9 days after randomization ]
  7. Fertilization rate (%) [ Time Frame: Day of oocyte retrieval (about 10 days after randomization) ]
  8. Implantation rate (%) [ Time Frame: About 4~5 weeks after Embryo transfer ]
  9. Chemical pregnancy (%) [ Time Frame: About 2 weeks after oocyte retrieval ]
  10. Clinical pregnancy (%) [ Time Frame: About 4~5 weeks after Embryo transfer ]
  11. Ongoing pregnancy (%) [ Time Frame: About 10~11 weeks after oocyte retrieval ]


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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051087


Locations
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Korea, Republic of
CHA Bundang Medical Center, CHA University
Gyeonggi-do, Korea, Republic of
CHA Gangnam Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT03051087    
Other Study ID Numbers: LG-GNCL001
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs