InfertilityNCT01100333
GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
This non-interventional study (NIS) is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator. Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Recombinant human follicle stimulating hormone (r-hFSH)
- How many people
- 2,552 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Jul 2011
- 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 Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Subjects undergoing Assisted Reproductive Technologies (ART) receiving Gonal-f in Germany
Who may be able to join
- Female subjects undergoing stimulation with Gonal-f in ART in accordance with the permitted indication
- Subjects below 35 years of age
- Subjects who have a Body mass index below 30
- Subjects with a basal FSH below 12 I.E./l and is downregulated in the long gonadotropin hormone releasing hormone agonist (GnRHa) Protocol
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin Charitè Berlin, Schumann Straße 20/21
Berlin, State of Berlin, 101107
About this study
Official title: Observational Study GONAL-f® Consort
This non-interventional study (NIS) is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator.
Read the detailed description
Since the introduction of the first recombinant human follicle stimulating hormone (FSH) preparation Gonal-f in the year 1996, a pure drug is available as raw material, which is independent of human urine due to biotechnological methods and consequently can be produced free of contaminating proteins. In accordance with the recommendations of European Medicines Agency (EMEA) in February 1999, on the basis of data from clinical studies, Gonal-f should be regarded as the more effective preparation in comparison to urinary FSH. Serono has developed a dose calculator, the CONSORT calculator, after analyzing the data from clinical studies for Gonal-f. This non-interventional study is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator. All subjects, who undergo stimulation with Gonal-f in preparation for a technology of the assisted conception in accordance with the permitted indication, will be included in this non-interventional study.
OBJECTIVES
Primary Objective:
- To examine, how far the dose recommended by the doctor for the first stimulation day varies from the dose recommended by the CONSORT calculator
- Conditions
- Infertility
- Being tested
- Recombinant human follicle stimulating hormone (r-hFSH)
- Keywords
- Infertility, Reproductive technologies, Assisted, r-hFSH, Gonal-f
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human follicle stimulating hormone (r-hFSH)Drug
Also called Gonal-f
Recombinant hFSH prescribed according to prescriber's judgement
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator
Measured: 6 month
Secondary outcomes (1)
Efficacy parameters
Total dose and the necessity of a dose adjustment during stimulation period, number of the obtained ova after hCG administration, the duration of the stimulation,stimulation dose on the last stimulation day
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startApr 2008
- Primary completionJul 2011
- Study completionJul 2011
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- W. Bilger, Study chair, Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100333
- Sponsor's protocol ID
- 700623-500
- Status last verified
- Jan 2013
- First submitted
- 24 Feb 2010
- Last updated
- 31 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study GONAL-f® Consort
- ClinicalTrials.gov ID
- NCT01100333
- Acronym / sponsor ID
- 700623-500
- Conditions
- Infertility
- Keywords
- Infertility, Reproductive technologies, Assisted, r-hFSH, Gonal-f
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,552 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Apr 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.
This non-interventional study (NIS) is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator.
Detailed description
Since the introduction of the first recombinant human follicle stimulating hormone (FSH) preparation Gonal-f in the year 1996, a pure drug is available as raw material, which is independent of human urine due to biotechnological methods and consequently can be produced free of contaminating proteins. In accordance with the recommendations of European Medicines Agency (EMEA) in February 1999, on the basis of data from clinical studies, Gonal-f should be regarded as the more effective preparation in comparison to urinary FSH. Serono has developed a dose calculator, the CONSORT calculator, after analyzing the data from clinical studies for Gonal-f. This non-interventional study is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator. All subjects, who undergo stimulation with Gonal-f in preparation for a technology of the assisted conception in accordance with the permitted indication, will be included in this non-interventional study.
OBJECTIVES
Primary Objective:
- To examine, how far the dose recommended by the doctor for the first stimulation day varies from the dose recommended by the CONSORT calculator
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects undergoing Assisted Reproductive Technologies (ART) receiving Gonal-f in Germany
Key inclusion criteria (4 listed)
- Female subjects undergoing stimulation with Gonal-f in ART in accordance with the permitted indication
- Subjects below 35 years of age
- Subjects who have a Body mass index below 30
- Subjects with a basal FSH below 12 I.E./l and is downregulated in the long gonadotropin hormone releasing hormone agonist (GnRHa) Protocol
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Recombinant human follicle stimulating hormone (r-hFSH)Also: Gonal-fRecombinant hFSH prescribed according to prescriber's judgement | Drug | – |
Primary outcome
Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator
Time frame: 6 month
1 secondary outcome
Efficacy parameters
Time frame: 6 month
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 31 Jul 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.
W. Bilger study chair
Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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 Merck KGaA, Darmstadt, Germany at 1 site in Germany.
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 4 inclusion and 0 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 31 Jul 2014. 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 Germany. 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?
Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator (time frame: 6 month). 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 31 Jul 2014.