InfertilityNCT01416987
A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 2 sites in South Korea.
Trial summary
This prospective study collected safety information from more than 600 participants treated with Pergoveris®. During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Pergoveris®
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 14 Aug 2011to 10 May 2018
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infertile participants
Who may be able to join
- Participants, who were eligible for Pergoveris® treatment according to the indication in the national label of Pergoveris®. The national label approved by Korea Food \& Drug Administration is "Pergoveris® in association with a follicle stimulating hormone(FSH) preparation was recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these participants were defined by an endogenous serum LH level less than (<)1.2 International units per liter IU/L"
Who cannot join
- According to national label
Trial locations and contacts
2 sites in 1 country.
About this study
This prospective study collected safety information from more than 600 participants treated with Pergoveris®.
During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) were collected for study purposes.The post marketing surveillance was based on all cases treated with Pergoveris®.
- Conditions
- Infertility
- Being tested
- Pergoveris®
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pergoveris®Drug
Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR)
Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.
Measured: 2463 days
Secondary outcomes (3)
Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography
Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported.
Measured: 2463 days
Number of Participants With Clinical Pregnancy as Per Safety Analysis Set
The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.
Measured: 2463 days
Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set
The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.
Measured: 2463 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study start14 Aug 2011
- Primary completion10 May 2018
- Study completion10 May 2018
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Ltd.
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416987
- Sponsor's protocol ID
- EMR200061-507
- Status last verified
- May 2019
- First submitted
- 12 Aug 2011
- Last updated
- 19 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
- ClinicalTrials.gov ID
- NCT01416987
- Acronym / sponsor ID
- EMR200061-507
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Ltd.
- Study start
- 14 Aug 2011 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study collected safety information from more than 600 participants treated with Pergoveris®.
During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) were collected for study purposes.The post marketing surveillance was based on all cases treated with Pergoveris®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infertile participants
Key inclusion criteria (1 listed)
- Participants, who were eligible for Pergoveris® treatment according to the indication in the national label of Pergoveris®. The national label approved by Korea Food \& Drug Administration is "Pergoveris® in association with a follicle stimulating hormone(FSH) preparation was recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these participants were defined by an endogenous serum LH level less than (<)1.2 International units per liter IU/L"
Key exclusion criteria (1 listed)
- According to national label
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 |
|---|---|---|
| Pergoveris®Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days. | Drug | – |
Primary outcome
Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR)
Time frame: 2463 days
Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.
3 secondary outcomes
Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography
Time frame: 2463 days
Number of Participants With Clinical Pregnancy as Per Safety Analysis Set
Time frame: 2463 days
Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set
Time frame: 2463 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- 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.
Medical Responsible study director
Merck Ltd.
2 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 Merck KGaA, Darmstadt, Germany 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 1 inclusion and 1 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 19 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2019). 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 Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) (time frame: 2463 days). 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 19 Jul 2019.