DRUG
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.
Timeline
From registration to results.
First posted
Feb 13, 2017
Study start
Oct 2016
Primary completion
Mar 2018
Study completion
Mar 2018
Results posted
Not reported
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.
Related trials
More studies on Ganirelix.
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist for Ovarian Stimulation in IVF/ICSI
Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) · Infertility, Female · Ovulation Induction
Early Phase 1
Not yet recruiting
189
2026-07
Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women
University of Delaware · Estrogen · Premenopause
Phase 4
Recruiting
30
2026-07
Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?
ART Fertility Clinics LLC · Healthy
Not applicable
Not yet recruiting
20
2026-05
INTEnsity of ovariaN Stimulation and Embryo Quality
Fundación Santiago Dexeus Font · Infertility
Phase 4
Completed
110
2026-04
Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.
Instituto Bernabeu · IVF
Phase 4
Completed
150
2026-03
IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
Hanoi Medical University · Infertility (IVF Patients) · Embryo Morphokinetics
Not applicable
Recruiting
148
2026-02
PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
University Hospital, Ghent · Ovarian Stimulation · Quality of Life
Phase 4
Recruiting
60
2025-12
DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT
Tam Anh TP. Ho Chi Minh General Hospital · Diminished Ovarian Reserve
Not applicable
Recruiting
730
2025-12
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.