An observational study in Infertility, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Germany. Open to female participants aged Up to 35 Years. Per ClinicalTrials.gov, last updated 2014-07-31.
Sponsored by Merck KGaA, Darmstadt, Germany · Observational
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.
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:
2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's enrollment of 2,552 is above the median of 200 across 722 observational studies indexed under Infertility.
Browse Infertility studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects undergoing Assisted Reproductive Technologies (ART) receiving Gonal-f in Germany
Inclusion Criteria:
Recombinant hFSH prescribed according to prescriber's judgement
Also known as: Gonal-f
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
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
Time frame: 6 month
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Merck KGaA, Darmstadt, Germany →