Multifollicular StimulationNCT01080729
An Observational Study to Compare the Dose of Gonal-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of Gonal-fTM FbM Pen
An observational study of Multifollicular Stimulation, run by Merck KGaA, Darmstadt, Germany at 1 site in Belgium.
Trial summary
This is a prospective, observational and multicentric study to compare the Gonal-f FbM (filled by mass) dose prescribed by the doctor with the Gonal-f FbM dose determined by the CONSORT (Consistency in r-FSH Starting doses for individualized treatment) calculator. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Multifollicular Stimulation
- What is being tested?
- Recombinant-follicle stimulating hormone (r-FSH)
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2009to Feb 2010
- 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 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Female subjects, who are being considered for an IVF/ICSI treatment and a Gonal-f treatment based on the PFS and inclusion and exclusion criteria will be eligible for the study.
Who may be able to join
- Female subjects who started treatment with Gonal-f on the basis of the decision of the investigator and indications and recommendations of the PFS
- Subjects who were at least 35 years old when the Gonal-f dose was administered (i.e. at the time of introducing individual variables of the subject in the CONSORT calculator for determining the dose)
- Subjects with BMI < 30 kg/m2
- Subjects who were in premature follicle phase (day 2-4), basal FSH ≤12 IU/l (measured in the center's laboratory)
- Subjects who were taking a gonadotropin-releasing hormone (GnRH) protocol agonist
- Subjects who consented to participate in the study and inform the investigator about their medical history
- Subjects who signed the written consent form, which stipulated that the subject could dropout of the study at any time without any negative consequences on future medical treatments
Who cannot join
- Subjects simultaneously participating in an interventional study
- Subjects following concomitant treatment with clomifene citrate
- Subjects presenting one of the contraindications described in the SPC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational and Multicentric Study to Compare the Dose of GONAL-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of GONAL-fTM FbM Pen
This is a prospective, observational and multicentric study to compare the Gonal-f FbM (filled by mass) dose prescribed by the doctor with the Gonal-f FbM dose determined by the CONSORT (Consistency in r-FSH Starting doses for individualized treatment) calculator.
Read the detailed description
The ovarian stimulation with the follicle-stimulating hormone (FSH) is the main element for the success of medically assisted procreation (MAP) technique. The possibility of predicting a poor ovarian response would thus enable the doctor to proactively define the treatment cycle and subject expectations. However, it is difficult to select the right dose of recombinant-human FSH (r-hFSH) to reach the "acceptable" number of oocytes. A series of reports, in which investigators identified different variables associated with ovarian response, appeared in the literature so as to develop a more structured approach with the aim of determining the initial Gonal-f dose in an MAP cycle.
After having reviewed the literature, following predictive factors present a strong correlation with the ovarian response:
- Initial serum FSH during the premature follicle phase (day 2-4 of the cycle),
- Body mass index (BMI; in kg/m2),
- Age,
- Initial number of antral follicles (day 2-4 of the cycle) determined in the ultrasound scan.
The relative importance of each of these factors was judged on the basis of a statistical model analysis and an r-hFSH dose (Gonal-f in international units [IU]) was attributed to each factor with a view of creating guidelines and determining the optimal FSH dose (using CONSORT dose calculator) to be used on the basis of the initial predictive characteristics/variables specific to the subject.
The purpose of this study is to compare the Gonal-f FbM dose prescribed by the doctor with the Gonal-f FbM dose determined by the CONSORT calculator.
A short questionnaire will be used to evaluate the ease of using the pre-filled Gonal-f (FbM) pen. The dosage and administration of Gonal-f shall be in accordance with the Product Features Summary (PFS) and current clinical practice in the centers.
OBJECTIVES
Primary objective:
- To study whether the Gonal-f FbM dose prescribed by the doctor is different from the dose recommended by the CONSORT dose calculator
Secondary objectives:
- To evaluate the ease of using the new generation Gonal-f pen for subjects
- To compare the Gonal-f dose finally used with the dose used during the previous treatment cycles (if this data is available)
- To put a figure to the total duration of the treatment, total quantity of gonadotropins taken and the number of clinical pregnancies
- In case of use of the CONSORT calculator: to estimate cancellations due to poor response This observational study will be conducted in 8 fertility centers in Belgium and Luxembourg as per the current clinical practice conditions in force at each center. Each center will recruit approximately 30 subjects to reach a total of approximately 250 subjects. The maximum number of treatment cycles to be evaluated in this project will be 600 over a period of approximately 6 months.
The CONSORT dose calculator is made available to all the participating centers via a secure web site. Each investigator will receive a user identification and password to access the system. The investigator will then introduce the 4 individual variables of the subject (basal FSH, BMI, age and number of antral follicles [follicles ≥2mm - <11mm]) in the CONSORT calculator, which will determine an individualized dose of Gonal-f for this specific subject. If the investigator does not agree with the dose calculated by CONSORT and opts for another dosage, he/she may indicate it directly in the CRF (Case Report Form). In this case, the Gonal-f dose will be based on the investigator's advice in accordance with the clinical practice in force in the center.
Follicle development shall be monitored in accordance with the current clinical practice of the center with diagnostic ultrasound and/or estradiol (E2) dosage until the local criteria for the administration of the human chorionic gonadotropin (hCG) is reached. Human chorionic gonadotropin will be administered in accordance with the current clinical practice of the center to reach final oocyte maturation. The date of administration of the hCG (Ovitrelle) will be indicated in the CRF.
- Conditions
- Multifollicular Stimulation
- Being tested
- Recombinant-follicle stimulating hormone (r-FSH)
- Keywords
- Ovulation induction, Ovarian Hyperstimulation Syndrome, Multifollicular stimulation, Pregnancy, Sperm injections, intracytoplasmic, Fertility
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant-follicle stimulating hormone (r-FSH)Drug
Also called GONAL-f™
The dosage and administration of r-FSH will be in accordance with the PFS and current clinical practice in the centers (300 IU/0.5 ml [22 micrograms/0.5 ml]; 450 IU/0.75 ml [33 micrograms/0.75 ml]; or 900 IU/1.5 ml [66 micrograms/1.5 ml].
The dosage and administration of recombinant-hCG (r-hCG; 250 micrograms/0.5 ml), injectable solution in a pre-filled syringe will also be in accordance with the PFS and current clinical practice in the centers (only if the doctor decides to start treatment with r-hCG).
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the initial Gonal-f FbM dose prescribed by the doctor and the initial Gonal-f FbM dose recommended by the CONSORT calculator
Measured: Before and after the treatement for 1 cycle over a period of 6 months
Secondary outcomes (1)
Secondary variables
Total Gonal-f dose used; subject satisfaction; duration of the treatment; Gonal-f dose used on the last day of stimulation; total dose of gonadotropins used; number of cases of ovarian hyper-stimulation syndrome (OHSS); number of cancelled cycles; number of clinical pregnancies; incidence and seriousness of OHSS
Measured: Before and after the treatement for 1 cycle over a period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multifollicular StimulationStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck N.V.-S.A., Belgium
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck N.V.-S.A., Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080729
- Sponsor's protocol ID
- 700623-508
- Status last verified
- Oct 2011
- First submitted
- 3 Mar 2010
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational and Multicentric Study to Compare the Dose of GONAL-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of GONAL-fTM FbM Pen
- ClinicalTrials.gov ID
- NCT01080729
- Acronym / sponsor ID
- 700623-508
- Conditions
- Multifollicular Stimulation
- Keywords
- Ovulation induction, Ovarian Hyperstimulation Syndrome, Multifollicular stimulation, Pregnancy, Sperm injections, intracytoplasmic, Fertility
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck N.V.-S.A., Belgium
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Mar 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 is a prospective, observational and multicentric study to compare the Gonal-f FbM (filled by mass) dose prescribed by the doctor with the Gonal-f FbM dose determined by the CONSORT (Consistency in r-FSH Starting doses for individualized treatment) calculator.
Detailed description
The ovarian stimulation with the follicle-stimulating hormone (FSH) is the main element for the success of medically assisted procreation (MAP) technique. The possibility of predicting a poor ovarian response would thus enable the doctor to proactively define the treatment cycle and subject expectations. However, it is difficult to select the right dose of recombinant-human FSH (r-hFSH) to reach the "acceptable" number of oocytes. A series of reports, in which investigators identified different variables associated with ovarian response, appeared in the literature so as to develop a more structured approach with the aim of determining the initial Gonal-f dose in an MAP cycle.
After having reviewed the literature, following predictive factors present a strong correlation with the ovarian response:
- Initial serum FSH during the premature follicle phase (day 2-4 of the cycle),
- Body mass index (BMI; in kg/m2),
- Age,
- Initial number of antral follicles (day 2-4 of the cycle) determined in the ultrasound scan.
The relative importance of each of these factors was judged on the basis of a statistical model analysis and an r-hFSH dose (Gonal-f in international units [IU]) was attributed to each factor with a view of creating guidelines and determining the optimal FSH dose (using CONSORT dose calculator) to be used on the basis of the initial predictive characteristics/variables specific to the subject.
The purpose of this study is to compare the Gonal-f FbM dose prescribed by the doctor with the Gonal-f FbM dose determined by the CONSORT calculator.
A short questionnaire will be used to evaluate the ease of using the pre-filled Gonal-f (FbM) pen. The dosage and administration of Gonal-f shall be in accordance with the Product Features Summary (PFS) and current clinical practice in the centers.
OBJECTIVES
Primary objective:
- To study whether the Gonal-f FbM dose prescribed by the doctor is different from the dose recommended by the CONSORT dose calculator
Secondary objectives:
- To evaluate the ease of using the new generation Gonal-f pen for subjects
- To compare the Gonal-f dose finally used with the dose used during the previous treatment cycles (if this data is available)
- To put a figure to the total duration of the treatment, total quantity of gonadotropins taken and the number of clinical pregnancies
- In case of use of the CONSORT calculator: to estimate cancellations due to poor response This observational study will be conducted in 8 fertility centers in Belgium and Luxembourg as per the current clinical practice conditions in force at each center. Each center will recruit approximately 30 subjects to reach a total of approximately 250 subjects. The maximum number of treatment cycles to be evaluated in this project will be 600 over a period of approximately 6 months.
The CONSORT dose calculator is made available to all the participating centers via a secure web site. Each investigator will receive a user identification and password to access the system. The investigator will then introduce the 4 individual variables of the subject (basal FSH, BMI, age and number of antral follicles [follicles ≥2mm - <11mm]) in the CONSORT calculator, which will determine an individualized dose of Gonal-f for this specific subject. If the investigator does not agree with the dose calculated by CONSORT and opts for another dosage, he/she may indicate it directly in the CRF (Case Report Form). In this case, the Gonal-f dose will be based on the investigator's advice in accordance with the clinical practice in force in the center.
Follicle development shall be monitored in accordance with the current clinical practice of the center with diagnostic ultrasound and/or estradiol (E2) dosage until the local criteria for the administration of the human chorionic gonadotropin (hCG) is reached. Human chorionic gonadotropin will be administered in accordance with the current clinical practice of the center to reach final oocyte maturation. The date of administration of the hCG (Ovitrelle) will be indicated in the CRF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female subjects, who are being considered for an IVF/ICSI treatment and a Gonal-f treatment based on the PFS and inclusion and exclusion criteria will be eligible for the study.
Key inclusion criteria (7 listed)
- Female subjects who started treatment with Gonal-f on the basis of the decision of the investigator and indications and recommendations of the PFS
- Subjects who were at least 35 years old when the Gonal-f dose was administered (i.e. at the time of introducing individual variables of the subject in the CONSORT calculator for determining the dose)
- Subjects with BMI < 30 kg/m2
- Subjects who were in premature follicle phase (day 2-4), basal FSH ≤12 IU/l (measured in the center's laboratory)
- Subjects who were taking a gonadotropin-releasing hormone (GnRH) protocol agonist
Key exclusion criteria (3 listed)
- Subjects simultaneously participating in an interventional study
- Subjects following concomitant treatment with clomifene citrate
- Subjects presenting one of the contraindications described in the SPC
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-follicle stimulating hormone (r-FSH)Also: GONAL-f™The dosage and administration of r-FSH will be in accordance with the PFS and current clinical practice in the centers (300 IU/0.5 ml [22 micrograms/0.5 ml]; 450 IU/0.75 ml [33 micrograms/0.75 ml]; or 900 IU/1.5 ml [66 micrograms/1.5 ml]. The dosage and administration of recombinant-hCG (r-hCG; 250 micrograms/0.5 ml), injectable solution in a pre-filled syringe will also be in accordance with the PFS and current clinical practice in the centers (only if the doctor decides to start treatment with r-hCG). | Drug | – |
Primary outcome
Comparison between the initial Gonal-f FbM dose prescribed by the doctor and the initial Gonal-f FbM dose recommended by the CONSORT calculator
Time frame: Before and after the treatement for 1 cycle over a period of 6 months
1 secondary outcome
Secondary variables
Time frame: Before and after the treatement for 1 cycle over a period of 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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 N.V.-S.A., Belgium
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 Multifollicular Stimulation, run by Merck KGaA, Darmstadt, Germany at 1 site in Belgium.
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 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 Belgium. 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 was stopped early. Results are not available in the source record.
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?
Comparison between the initial Gonal-f FbM dose prescribed by the doctor and the initial Gonal-f FbM dose recommended by the CONSORT calculator (time frame: Before and after the treatement for 1 cycle over a period of 6 months). 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 2 Jul 2014.