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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01100333
First received: February 24, 2010
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Infertility
 Drug: Recombinant human follicle stimulating hormone (r-hFSH)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study GONAL-f® Consort

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Merck KGaA:

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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy parameters [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

Whole Blood


Enrollment: 2552
Study Start Date: April 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Recombinant human follicle stimulating hormone (r-hFSH)
    Recombinant hFSH prescribed according to prescriber's judgement
    Other Name: Gonal-f
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
  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects undergoing Assisted Reproductive Technologies (ART) receiving Gonal-f in Germany

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100333

Locations
Germany
Universitätsmedizin Charitè Berlin, Schumann Straße 20/21
Berlin, Germany, 101107
Sponsors and Collaborators
Merck KGaA
Investigators
Study Chair: W. Bilger Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01100333     History of Changes
Other Study ID Numbers: 700623-500
Study First Received: February 24, 2010
Last Updated: January 17, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Merck KGaA:
Infertility
Reproductive technologies, Assisted
r-hFSH
Gonal-f

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013