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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Infertility

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01100333

700623-500

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,552 patients

Sex: Female

Ages: Under 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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