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

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT01100333

Collaborator

(none)

2,552

Enrollment

Location

Duration (Months)

65.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Recombinant human follicle stimulating hormone (r-hFSH)

Detailed 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

Study Design

Study Type:

Observational

Actual Enrollment :

2552 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Study GONAL-f® Consort

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Outcome Measures

Primary Outcome Measures

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

Efficacy parameters [6 month]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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