NCT03051087

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

February 7, 2017

Last Update Submit

June 28, 2019

Conditions

Controlled Ovarian Stimulation

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    about 10 days after randomization

Secondary Outcomes (11)

  • Proportion of subjects with LH (luteinizing hormone) rise > 10 mIU/mL

    about 8~9 days after randomization (visit 4)

  • Oocyte quality

    Day of oocyte retrieval (about 10 days after randomization)

  • Total administration dosage (IU) of Follitrope® PFS

    During 8~9 days after randomization (until administration hCG)

  • Total administration duration (day) of Follitrope® PFS

    During 8~9 days after randomization (until administration hCG)

  • Total administration dosage (mL) of Ganilever PFS or Orgalutran®

    From 4~5 days after randomization to 8~9 days after randomization

  • +6 more secondary outcomes

Study Arms (2)

Ganilever (ganirelix acetate)

EXPERIMENTAL

Prefilled syringe / 0.25mg/0.5mL

Drug: Ganirelix acetate

Orgalutran (ganirelix acetate)

ACTIVE COMPARATOR

Prefilled syringe / 0.25mg/0.5mL

Drug: Ganirelix acetate

Interventions

Ganirelix acetateDRUG
Ganilever (ganirelix acetate)Orgalutran (ganirelix acetate)

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHA Bundang Medical Center, CHA University

Gyeonggi-do, South Korea

Location

CHA Gangnam Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

ganirelix

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 13, 2017

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 2, 2019

Record last verified: 2019-06

Locations

KR(2)