GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)

Merck KGaA, Darmstadt, Germany2,552 enrolled

Overview

This non-interventional study (NIS) is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator.

Since the introduction of the first recombinant human follicle stimulating hormone (FSH) preparation Gonal-f in the year 1996, a pure drug is available as raw material, which is independent of human urine due to biotechnological methods and consequently can be produced free of contaminating proteins. In accordance with the recommendations of European Medicines Agency (EMEA) in February 1999, on the basis of data from clinical studies, Gonal-f should be regarded as the more effective preparation in comparison to urinary FSH. Serono has developed a dose calculator, the CONSORT calculator, after analyzing the data from clinical studies for Gonal-f. This non-interventional study is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator. All subjects, who undergo stimulation with Gonal-f in preparation for a technology of the assisted conception in accordance with the permitted indication, will be included in this non-interventional study. OBJECTIVES Primary Objective: * To examine, how far the dose recommended by the doctor for the first stimulation day varies from the dose recommended by the CONSORT calculator

Study Type

OBSERVATIONAL

Enrollment

2,552

Conditions

Infertility

Interventions

Recombinant human follicle stimulating hormone (r-hFSH)DRUG

Recombinant hFSH prescribed according to prescriber's judgement

Eligibility

Sex: FEMALEMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female subjects undergoing stimulation with Gonal-f in ART in accordance with the permitted indication * Subjects below 35 years of age * Subjects who have a Body mass index below 30 * Subjects with a basal FSH below 12 I.E./l and is downregulated in the long gonadotropin hormone releasing hormone agonist (GnRHa) Protocol

Locations (1)

Universitätsmedizin Charitè Berlin, Schumann Straße 20/21

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator

Time frame: 6 month

Secondary Outcomes

Efficacy parameters

Total dose and the necessity of a dose adjustment during stimulation period, number of the obtained ova after hCG administration, the duration of the stimulation,stimulation dose on the last stimulation day

Time frame: 6 month

Data from ClinicalTrials.gov

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