InfertilityNCT02835469
A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility
An observational study of Infertility, run by Ferring Pharmaceuticals at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Menotrophin
- How many people
- 412 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to 1 Feb 2019
- Phase
- Observational
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Fertility clinics
Who may be able to join
- Decision made to prescribe Menopur® multidose according to Summary of product characteristics
- The study cycle will be either
- 1st controlled ovarian stimulation cycle ever, or
- 2nd controlled ovarian stimulation cycle ever, or
- 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)
Who cannot join
- Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)
- Diagnosed as "poor responder", defined as either
- >20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or
- any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or
- development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle
- Ovarian hyperstimulation syndrome (OHSS)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CL Hospital (there may be other sites in this country)
Gwangju
About this study
Official title: Non-Interventional Clinical Study on Efficacy and Safety of Highly Purified Human Menopausal Gonadotrophin (HP-hMG) Menopur® Multidose in Korean Female Patients With Infertility
The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose
- Conditions
- Infertility
- Being tested
- Menotrophin
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenotrophinDrug
Also called Menopur® Multidose
| Study group | Role | What they receive |
|---|---|---|
| Menopur® Multidose | Treatment according to routine clinical practice. Receives: Drug: Menotrophin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Defined as presence of at least 1 intrauterine pregnancy with a viable fetus
Measured: 10-11 weeks after embryo transfer
Secondary outcomes (7)
Mean Follicle Stimulating Hormone (FSH) level
Measured: At baseline and last stimulation day (max 20 days after start of stimulation)
Mean Luteinizing Hormone (LH) level
Measured: At baseline and last stimulation day (max 20 days after start of stimulation)
Mean Estradiol 2 (E2) level
Measured: At baseline and last stimulation day (max 20 days after start of stimulation)
Mean endometrial thickness
Measured by transvaginal ultrasound
Measured: On last stimulation day (max 20 days after start of stimulation)
Follicular development
Number and size of follicles measured by transvaginal ultrasound
Measured: On last stimulation day (max 20 days after start of stimulation)
Number of oocytes retrieved
Measured: 36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration
Fertilization rate
Number of oocytes with 2 pronuclei divided by number of metaphase II oocytes
Measured: 1 day 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 posted18 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835469
- Sponsor's protocol ID
- 000258
- Status last verified
- Mar 2019
- First submitted
- 28 Jun 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Clinical Study on Efficacy and Safety of Highly Purified Human Menopausal Gonadotrophin (HP-hMG) Menopur® Multidose in Korean Female Patients With Infertility
- ClinicalTrials.gov ID
- NCT02835469
- Acronym / sponsor ID
- 000258
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 18 Jul 2016 (estimated)
- 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.
The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Menopur® Multidose | – | Drug: MenotrophinTreatment according to routine clinical practice. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Fertility clinics
Key inclusion criteria (5 listed)
- Decision made to prescribe Menopur® multidose according to Summary of product characteristics
- The study cycle will be either
Key exclusion criteria (6 listed)
- Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)
- Diagnosed as "poor responder", defined as either
- Ovarian hyperstimulation syndrome (OHSS)
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 |
|---|---|---|
| MenotrophinAlso: Menopur® Multidose | Drug | Menopur® Multidose |
Primary outcome
Ongoing pregnancy rate
Time frame: 10-11 weeks after embryo transfer
Defined as presence of at least 1 intrauterine pregnancy with a viable fetus
7 secondary outcomes
Mean Follicle Stimulating Hormone (FSH) level
Time frame: At baseline and last stimulation day (max 20 days after start of stimulation)
Mean Luteinizing Hormone (LH) level
Time frame: At baseline and last stimulation day (max 20 days after start of stimulation)
Mean Estradiol 2 (E2) level
Time frame: At baseline and last stimulation day (max 20 days after start of stimulation)
Mean endometrial thickness
Time frame: On last stimulation day (max 20 days after start of stimulation)
Follicular development
Time frame: On last stimulation day (max 20 days after start of stimulation)
Number of oocytes retrieved
Time frame: 36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration
Fertilization rate
Time frame: 1 day 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 28 Mar 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.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ferring Pharmaceuticals at 1 site 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 5 inclusion and 6 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Ongoing pregnancy rate (time frame: 10-11 weeks after embryo transfer). 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 28 Mar 2019.