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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT03051087 (opens ClinicalTrials.gov in a new tab)Other idLG-GNCL001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
255 participants (actual)
Sponsor
LG Life Sciences · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

South Korea

Start
Oct 2016
Primary completion
Mar 2018
Completion
Mar 2018
First posted
13 Feb 2017
Last update posted
2 Jul 2019
Conditions
Controlled Ovarian Stimulation

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 4

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

    NCT03051087

    Oct 2016 to Mar 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Ganirelix acetateDrug

Arms2

  • Experimental

    Ganilever (ganirelix acetate)

    Prefilled syringe / 0.25mg/0.5mL

  • Active comparator

    Orgalutran (ganirelix acetate)

    Prefilled syringe / 0.25mg/0.5mL

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of oocytes retrieved

    Time frame · about 10 days after randomization

Secondary outcomes(11)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 39 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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