Infertility
Conditions
Keywords
Infertility, Reproductive technologies, Assisted, r-hFSH, Gonal-f
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.
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
Interventions
Recombinant hFSH prescribed according to prescriber's judgement
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed