Current partner codePEPTIDESDE
NCT03051087·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

255

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

Ganirelix acetate

Timeline

From registration to results.

  1. First posted

    Feb 13, 2017

  2. Study start

    Oct 2016

  3. Primary completion

    Mar 2018

  4. Study completion

    Mar 2018

  5. Results posted

    Not reported

  6. Registry updated

    Jul 2, 2019

Outcomes

What the study measures.

Primary outcomes

Number of oocytes retrieved

Time frame · about 10 days after randomization

Secondary outcomes

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

Time frame · about 8~9 days after randomization (visit 4)

Oocyte quality

Time frame · Day of oocyte retrieval (about 10 days after randomization)

Total administration dosage (IU) of Follitrope® PFS

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

Total administration duration (day) of Follitrope® PFS

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

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

Time frame · From 4~5 days after randomization to 8~9 days after randomization

Total administration duration (day) of Ganilever PFS or Orgalutran®

Time frame · From 4~5 days after randomization to 8~9 days after randomization

Fertilization rate (%)

Time frame · Day of oocyte retrieval (about 10 days after randomization)

Implantation rate (%)

Time frame · About 4~5 weeks after Embryo transfer

Chemical pregnancy (%)

Time frame · About 2 weeks after oocyte retrieval

Clinical pregnancy (%)

Time frame · About 4~5 weeks after Embryo transfer

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
Yes

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

Study locations

2 registered sites.

South Korea. Showing up to 24 locations stored in the fast local snapshot.

CHA Bundang Medical Center, CHA University

Gyeonggi-do, South Korea

CHA Gangnam Medical Center

Seoul, South Korea

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Ganirelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.