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

This study has been terminated.
Sponsor:
Collaborator:
Merck N.V.-S.A., Belgium
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01080729
First received: March 3, 2010
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Multifollicular Stimulation
Drug: Recombinant-follicle stimulating hormone (r-FSH)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational and Multicentric 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Comparison between the initial Gonal-f FbM dose prescribed by the doctor and the initial Gonal-f FbM dose recommended by the CONSORT calculator [ Time Frame: Before and after the treatement for 1 cycle over a period of 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary variables [ Time Frame: Before and after the treatement for 1 cycle over a period of 6 months ] [ Designated as safety issue: Yes ]
    Total Gonal-f dose used; subject satisfaction; duration of the treatment; Gonal-f dose used on the last day of stimulation; total dose of gonadotropins used; number of cases of ovarian hyper-stimulation syndrome (OHSS); number of cancelled cycles; number of clinical pregnancies; incidence and seriousness of OHSS


Biospecimen Retention:   Samples Without DNA

Blood Serum


Enrollment: 25
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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).

    Other Name: GONAL-f™
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Female subjects, who are being considered for an IVF/ICSI treatment and a Gonal-f treatment based on the PFS and inclusion and exclusion criteria will be eligible for the study.

Criteria

Inclusion Criteria:

  • Female subjects who started treatment with Gonal-f on the basis of the decision of the investigator and indications and recommendations of the PFS
  • Subjects who were at least 35 years old when the Gonal-f dose was administered (i.e. at the time of introducing individual variables of the subject in the CONSORT calculator for determining the dose)
  • Subjects with BMI < 30 kg/m2
  • Subjects who were in premature follicle phase (day 2-4), basal FSH ≤12 IU/l (measured in the center's laboratory)
  • Subjects who were taking a gonadotropin-releasing hormone (GnRH) protocol agonist
  • Subjects who consented to participate in the study and inform the investigator about their medical history
  • Subjects who signed the written consent form, which stipulated that the subject could dropout of the study at any time without any negative consequences on future medical treatments

Exclusion Criteria:

  • Subjects simultaneously participating in an interventional study
  • Subjects following concomitant treatment with clomifene citrate
  • Subjects presenting one of the contraindications described in the SPC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080729

Locations
Belgium
ZNA Middelheim
Antwerpen, Lindendreef 1, Belgium, B-2020
Sponsors and Collaborators
Merck KGaA
Merck N.V.-S.A., Belgium
Investigators
Study Director: Medical Responsible Merck N.V.-S.A., Belgium
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080729     History of Changes
Other Study ID Numbers: 700623-508
Study First Received: March 3, 2010
Last Updated: October 13, 2011
Health Authority: Belgium: Commissie Medische Ethiek

Keywords provided by Merck KGaA:
Ovulation induction
Ovarian Hyperstimulation Syndrome
Multifollicular stimulation
Pregnancy
Sperm injections, intracytoplasmic
Fertility

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014