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

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LG Life Sciences

Status and phase

Completed
Phase 4

Conditions

Controlled Ovarian Stimulation

Treatments

Drug: Ganirelix acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT03051087
LG-GNCL001

Details and patient eligibility

About

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

Enrollment

255 patients

Sex

Female

Ages

20 to 39 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

255 participants in 2 patient groups

Ganilever (ganirelix acetate)
Experimental group
Description:
Prefilled syringe / 0.25mg/0.5mL
Treatment:
Drug: Ganirelix acetate
Orgalutran (ganirelix acetate)
Active Comparator group
Description:
Prefilled syringe / 0.25mg/0.5mL
Treatment:
Drug: Ganirelix acetate

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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