Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed,
and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government
operating status and resumption of normal operations can be found at opm.gov.
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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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
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).
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 Outcome Measures
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 35 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
Subjects simultaneously participating in an interventional study
Subjects following concomitant treatment with clomifene citrate
Subjects presenting one of the contraindications described in the SPC