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An Observational Study to Compare the Dose of Gonal-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of Gonal-fTM FbM Pen

NCT01080729 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2014-07-02

No results posted yet for this study

Summary

This is a prospective, observational and multicentric study to compare the Gonal-f FbM (filled by mass) dose prescribed by the doctor with the Gonal-f FbM dose determined by the CONSORT (Consistency in r-FSH Starting doses for individualized treatment) calculator.

Conditions

  • Multifollicular Stimulation

Interventions

DRUG

Recombinant-follicle stimulating hormone (r-FSH)

The dosage and administration of r-FSH will be in accordance with the PFS and current clinical practice in the centers (300 IU/0.5 ml \[22 micrograms/0.5 ml\]; 450 IU/0.75 ml \[33 micrograms/0.75 ml\]; or 900 IU/1.5 ml \[66 micrograms/1.5 ml\]. The dosage and administration of recombinant-hCG (r-hCG; 250 micrograms/0.5 ml), injectable solution in a pre-filled syringe will also be in accordance with the PFS and current clinical practice in the centers (only if the doctor decides to start treatment with r-hCG).

Sponsors & Collaborators

  • Merck N.V.-S.A., Belgium

    collaborator OTHER

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck N.V.-S.A., Belgium

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01080729 on ClinicalTrials.gov