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

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck N.V.-S.A., Belgium
• Treatments: Follicle Stimulating Hormone; Hormones

Criteria

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