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

Infertility Clinical Trial

Official title:

Observational Study GONAL-f® Consort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100333
• Other study ID #: 700623-500
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: July 30, 2014
• Start date: April 2008
• Est. completion date: July 2011

Study information

• Verified date: January 2013
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2552
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Recombinant human follicle stimulating hormone (r-hFSH)
Recombinant hFSH prescribed according to prescriber's judgement

Locations

Country	Name	City	State
Germany	Universitätsmedizin Charitè Berlin, Schumann Straße 20/21	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No