- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080729
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
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Lindendreef 1
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Antwerpen, Lindendreef 1, Belgium, B-2020
- ZNA Middelheim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Subjects simultaneously participating in an interventional study
- Subjects following concomitant treatment with clomifene citrate
- Subjects presenting one of the contraindications described in the SPC
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Before and after the treatement for 1 cycle over a period of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary variables
Time Frame: Before and after the treatement for 1 cycle over a period of 6 months
|
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
|
Before and after the treatement for 1 cycle over a period of 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Medical Responsible, Merck N.V.-S.A., Belgium
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 700623-508
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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