An observational study in Multifollicular Stimulation, sponsored by Merck KGaA, Darmstadt, Germany. Terminated at 1 site in Belgium. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2014-07-02.
Sponsored by Merck KGaA, Darmstadt, Germany · Observational
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.
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:
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:
Secondary objectives:
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.
Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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).
Also known as: GONAL-f™
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
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
Time frame: Before and after the treatement for 1 cycle over a period of 6 months
This study is terminated, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Merck KGaA, Darmstadt, Germany