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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Observational Study GONAL-f® Consort

Conditions
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Infertility

Intervention / Treatment
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* Drug: Recombinant human follicle stimulating hormone (r-hFSH)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Recombinant human follicle stimulating hormone (r-hFSH)|Recombinant hFSH prescribed according to prescriber's judgement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Reproductive technologies, Assisted, r-hFSH, Gonal-f