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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2552 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-07-31

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

Conditions

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Infertility

Keywords

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Infertility Reproductive technologies, Assisted r-hFSH Gonal-f

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Recombinant human follicle stimulating hormone (r-hFSH)

Recombinant hFSH prescribed according to prescriber's judgement

Intervention Type DRUG

Other Intervention Names

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Gonal-f

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

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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W. Bilger

Role: STUDY_CHAIR

Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

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Universitätsmedizin Charitè Berlin, Schumann Straße 20/21

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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700623-500

Identifier Type: -

Identifier Source: org_study_id