Infertility, FemalePhase 4NCT02458768
Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.
A Phase 4 study testing IVF-M HP Inj. and Menopur® Inj. in people with Infertility, Female, run by LG Life Sciences.
Trial summary
The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro fertilization and embryo transfer (IVF-ET) among the assisted reproductive technologies. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- IVF-M HP Inj. and Menopur® Inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Nov 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult
Who may be able to join
- Adult women from 20 through 39 years of age at the screening
- Subjects with the mean menstrual cycle day (MCD) of 25 to 35 days
- Subjects with the Follicle Stimulating Hormone (FSH) concentration at the screening not exceeding the upper limit of the normal range (ULN)
- Those diagnosed with infertility due to at least one of the following causes of infertility
- Fallopian tubal factor
- Infertility due to unknown cause
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- Male infertility
- Complex factor
- Subjects with the normal ovarian and uterine function
- Subjects with not more than 3 times of the prior experience of in vitro fertilization
- Subjects who had neither administered clomiphene citrate within 30 days nor gonadotropin within 14 days of the IP administration day
- Subjects who were informed on the objective, method and effect etc. of the clinical study and signed the informed consent form
Who cannot join
- Subjects contraindicated to pregnancy
- Subjects with BMI > 30 (BMI; kg/m2)
- Subjects diagnosed with polycystic ovary syndrome (PCOS)
- Subjects who had experienced previously at least Grade 4 ovarian hyperstimulation syndrome (OHSS)
- Subjects with poor response to gonadotropin (According to the Bologna criteria* below) *At least two of the following three features must be present:
- ① Advanced maternal age (>=40 years) or any other risk factor for Poor Ovarian Response (POR)
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- ② A previous POR (<=3 oocyte with a conventional stimulation protocol)
- ③ An abnormal ovarian reserve test (i.e. Antral follicle Count (AFC) < 5 follicles or Anti-Mullerian hormone (AMH) < 0.5 ng/ml)
- Those with abnormal metrorrhagia due to unknown cause at the screening
- Subjects with submucosal uterine leiomyoma
- Subjects with at least borderline ovarian tumor
- Subjects with a history or malignant tumor in breast
- Subjects with hydrosalpinx not removed by operation
- Subjects with the Thyroid Stimulating Hormone (TSH) level out of the normal range at the screening
- Subjects with a history of malignant tumor within 5 years prior to the screening
- Subjects with severe disease potentially affecting the study such as pituitary insufficiency upon the investigator's judgment (e.g., heart failure, renal failure, hepatic failure or adrenal insufficiency etc.)
- Subject with HIV- or syphilis-positive result at the screening
- Subjects with a psychiatric disorder at the screening or those who failed in understanding the objective and method of this clinical study
- Subject diagnosed with alcohol or drug abuse within 3 months prior to the screening
- Subjects with a history of hypersensitivity to the investigational products of this clinical study
- Subjects with a current or history of thromboembolism in vein or artery
- Subjects with a history of genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Subjects who had participated in another clinical study related to a drug administration after the enrollment in this study or who had participated in another clinical study within 3 months prior to the enrollment in this study
- Others including the subjects for whom it was considered difficult to conduct this clinical study upon the principal investigator's judgment
About this study
Official title: A Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of s.c. Administration of IVF-M HP Inj. Versus Menopur® Inj. in Infertility Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies (ART) Such as in Vitro Fertilization-embryo Transfer (IVF-ET)
The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro fertilization and embryo transfer (IVF-ET) among the assisted reproductive technologies.
- Conditions
- Infertility, Female
- Being tested
- IVF-M HP Inj., Menopur® Inj.
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF-M HP Inj.Drug
Menopur® Inj.Drug
| Study group | Role | What they receive |
|---|---|---|
| IVF-M HP Inj. | Experimental | administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). Receives: Drug: IVF-M HP Inj. |
| Menopur® Inj. | Active comparator | administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). Receives: Drug: Menopur® Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Retrieved Oocytes
Measured: 36 hrs (±3 hrs) after administration of the ovulation stimulant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startJul 2013
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infertility, FemaleStudies 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
- 112 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
- NCT02458768
- Sponsor's protocol ID
- LG-IMHCL001
- Status last verified
- May 2015
- First submitted
- 28 May 2015
- Last updated
- 3 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of s.c. Administration of IVF-M HP Inj. Versus Menopur® Inj. in Infertility Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies (ART) Such as in Vitro Fertilization-embryo Transfer (IVF-ET)
- ClinicalTrials.gov ID
- NCT02458768
- Acronym / sponsor ID
- LG-IMHCL001
- Conditions
- Infertility, Female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Nov 2014 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Posted 3 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro fertilization and embryo transfer (IVF-ET) among the 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 |
|---|---|---|
| IVF-M HP Inj. | Experimental | Drug: IVF-M HP Inj.administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). |
| Menopur® Inj. | Active comparator | Drug: Menopur® Inj.administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Adult women from 20 through 39 years of age at the screening
- Subjects with the mean menstrual cycle day (MCD) of 25 to 35 days
- Subjects with the Follicle Stimulating Hormone (FSH) concentration at the screening not exceeding the upper limit of the normal range (ULN)
- Those diagnosed with infertility due to at least one of the following causes of infertility
- Subjects with the normal ovarian and uterine function
Key exclusion criteria (24 listed)
- Subjects contraindicated to pregnancy
- Subjects with BMI > 30 (BMI; kg/m2)
- Subjects diagnosed with polycystic ovary syndrome (PCOS)
- Subjects who had experienced previously at least Grade 4 ovarian hyperstimulation syndrome (OHSS)
- Subjects with poor response to gonadotropin (According to the Bologna criteria* below) *At least two of the following three features must be present:
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 |
|---|---|---|
| IVF-M HP Inj. | Drug | IVF-M HP Inj. |
| Menopur® Inj. | Drug | Menopur® Inj. |
Primary outcome
Number of Retrieved Oocytes
Time frame: 36 hrs (±3 hrs) after administration of the ovulation stimulant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IVF-M HP Inj. and Menopur® Inj. in people with Infertility, Female, run by LG Life Sciences.
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 12 inclusion and 24 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 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 3 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Retrieved Oocytes (time frame: 36 hrs (±3 hrs) after administration of the ovulation stimulant). 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 3 Feb 2016.