InfertilityNCT01202123
Post Marketing Surveillance of MENOPUR
An observational study of Infertility, run by Ferring Pharmaceuticals at 19 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- How many people
- 2,501 participants
- Where
- 19 sitesSouth Korea
- Study dates
- Dec 2008to Feb 2014
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Infertile women
Who may be able to join
- Anovulation in women (WHO group II)
- Controlled ovarian hyperstimulation cases for ART
Who cannot join
- Hypersensitivity to MENOPUR
- Pregnancy, lactation or contraindication to pregnancy
- Ovarian cysts not related to polycystic ovarian syndrome
- Abnormal uterine bleeding
- Tumors in uterus, ovaries and breasts
- Ovarian hyperstimulation syndrome
Show all 9Show fewer
- Thromboembolism or history of it
- Infertile due to other reason than anovulation
- High FSH level indication primary ovarian failure
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
Seoul´s Women´s Hospital
Bucheon-si, Gyeonggi Province
Busan Maria hospital
Busan, Busan
Daegu Maria
Daegu, Daegu
Daejeon Maria
Daejeon, Daejeon
Daejeon Seoul Women Hospital
Daejeon, Daejeon
Ellemedi Women Clinic
Daejeon, Daejeon
Miz Women's Hospital
Daejeon, Daejeon Metropolitan City
Gumi CHA University Medical Center
Gumi, Kyoungbuk Province
Ilsan Maria Hospital
Ilsan, Gyeonggi Province
Incheon Seoul women Hospital
Incheon, Incheon
Premedi Women's Clinic
Kwangju, Kwangju Metropolitan City
Cheil General Hospital & Women's Healthcare Center
Seoul, Seoul
Gangseo Mizmedi Hospital
Seoul, Seoul
Hamchoon women clinic
Seoul, Seoul
Maria Plus Hospital
Seoul, Seoul
Samsung Medical Center
Seoul, Seoul
Songnae Maria Hospital
Seoul, Seoul
Maria Hospital
Seoul, ´Shinseoul-dong, Dongdaemun-gu
Mama Papa & Baby Hospital
Ulsan, Kyoungnam Province
About this study
The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.
- Conditions
- Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of follicles per cycle
An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded
Measured: Up to 6 weeks
Secondary outcomes (1)
Number of adverse events
An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startDec 2008
- Primary completionNov 2013
- Study completionFeb 2014
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
- 2,501 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
- NCT01202123
- Sponsor's protocol ID
- FE999906 CS10
- Status last verified
- Feb 2014
- First submitted
- 3 Sep 2010
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of MENOPUR
- ClinicalTrials.gov ID
- NCT01202123
- Acronym / sponsor ID
- FE999906 CS10
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,501 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Sep 2010 (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 evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Infertile women
Key inclusion criteria (2 listed)
- Anovulation in women (WHO group II)
- Controlled ovarian hyperstimulation cases for ART
Key exclusion criteria (9 listed)
- Hypersensitivity to MENOPUR
- Pregnancy, lactation or contraindication to pregnancy
- Ovarian cysts not related to polycystic ovarian syndrome
- Abnormal uterine bleeding
- Tumors in uterus, ovaries and breasts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of follicles per cycle
Time frame: Up to 6 weeks
An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded
1 secondary outcome
Number of adverse events
Time frame: Up to 6 weeks
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 21 Feb 2014.
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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
19 sites 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 19 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 2 inclusion and 9 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 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
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 follicles per cycle (time frame: Up to 6 weeks). 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 21 Feb 2014.