Controlled Ovarian StimulationPhase 4NCT03051087
To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®
A Phase 4 study testing Ganirelix acetate in people with Controlled Ovarian Stimulation, run by LG Life Sciences at 2 sites in South Korea.
Trial summary
to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Controlled Ovarian Stimulation
- What is being tested?
- Ganirelix acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Oct 2016to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
CHA Bundang Medical Center, CHA University
Gyeonggi-do
CHA Gangnam Medical Center
Seoul
About this study
Official 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
to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies
- Conditions
- Controlled Ovarian Stimulation
- Being tested
- Ganirelix acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganirelix acetateDrug
| Study group | Role | What they receive |
|---|---|---|
| Ganilever (ganirelix acetate) | Experimental | Prefilled syringe / 0.25mg/0.5mL Receives: Drug: Ganirelix acetate |
| Orgalutran (ganirelix acetate) | Active comparator | Prefilled syringe / 0.25mg/0.5mL Receives: Drug: Ganirelix acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Measured: about 10 days after randomization
Secondary outcomes (11)
Proportion of subjects with LH (luteinizing hormone) rise > 10 mIU/mL
Measured: about 8~9 days after randomization (visit 4)
Oocyte quality
Measured: Day of oocyte retrieval (about 10 days after randomization)
Total administration dosage (IU) of Follitrope® PFS
Measured: During 8~9 days after randomization (until administration hCG)
Total administration duration (day) of Follitrope® PFS
Measured: During 8~9 days after randomization (until administration hCG)
Total administration dosage (mL) of Ganilever PFS or Orgalutran®
Measured: From 4~5 days after randomization to 8~9 days after randomization
Total administration duration (day) of Ganilever PFS or Orgalutran®
Measured: From 4~5 days after randomization to 8~9 days after randomization
Fertilization rate (%)
Measured: Day of oocyte retrieval (about 10 days after randomization)
Implantation rate (%)
Measured: About 4~5 weeks after Embryo transfer
Chemical pregnancy (%)
Measured: About 2 weeks after oocyte retrieval
Clinical pregnancy (%)
Measured: About 4~5 weeks after Embryo transfer
Ongoing pregnancy (%)
Measured: About 10~11 weeks after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study startOct 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Controlled Ovarian StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051087
- Sponsor's protocol ID
- LG-GNCL001
- Status last verified
- Jun 2019
- First submitted
- 7 Feb 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03051087
- Acronym / sponsor ID
- LG-GNCL001
- Conditions
- Controlled Ovarian Stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganilever (ganirelix acetate) | Experimental | Drug: Ganirelix acetatePrefilled syringe / 0.25mg/0.5mL |
| Orgalutran (ganirelix acetate) | Active comparator | Drug: Ganirelix acetatePrefilled syringe / 0.25mg/0.5mL |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganirelix acetate | Drug | Ganilever (ganirelix acetate), Orgalutran (ganirelix acetate) |
Primary outcome
Number of oocytes retrieved
Time frame: about 10 days after randomization
11 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
Ongoing pregnancy (%)
Time frame: About 10~11 weeks after oocyte retrieval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ganirelix acetate in people with Controlled Ovarian Stimulation, run by LG Life Sciences at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes retrieved (time frame: about 10 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.