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Completed

NCT Number: NCT03051087

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

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

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Key information

Conditions

Controlled Ovarian Stimulation

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CHA Bundang Medical Center, CHA University, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ganirelix acetate

Drug

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: about 10 days after randomization

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 13, 2017
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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