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: July 1, 2014
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™
  Hide Detailed Description

Detailed Description:

The ovarian stimulation with the follicle-stimulating hormone (FSH) is the main element for the success of medically assisted procreation (MAP) technique. The possibility of predicting a poor ovarian response would thus enable the doctor to proactively define the treatment cycle and subject expectations. However, it is difficult to select the right dose of recombinant-human FSH (r-hFSH) to reach the "acceptable" number of oocytes. A series of reports, in which investigators identified different variables associated with ovarian response, appeared in the literature so as to develop a more structured approach with the aim of determining the initial Gonal-f dose in an MAP cycle.

After having reviewed the literature, following predictive factors present a strong correlation with the ovarian response:

  • Initial serum FSH during the premature follicle phase (day 2-4 of the cycle),
  • Body mass index (BMI; in kg/m2),
  • Age,
  • Initial number of antral follicles (day 2-4 of the cycle) determined in the ultrasound scan.

The relative importance of each of these factors was judged on the basis of a statistical model analysis and an r-hFSH dose (Gonal-f in international units [IU]) was attributed to each factor with a view of creating guidelines and determining the optimal FSH dose (using CONSORT dose calculator) to be used on the basis of the initial predictive characteristics/variables specific to the subject.

The purpose of this study is to compare the Gonal-f FbM dose prescribed by the doctor with the Gonal-f FbM dose determined by the CONSORT calculator.

A short questionnaire will be used to evaluate the ease of using the pre-filled Gonal-f (FbM) pen. The dosage and administration of Gonal-f shall be in accordance with the Product Features Summary (PFS) and current clinical practice in the centers.

OBJECTIVES

Primary objective:

  • To study whether the Gonal-f FbM dose prescribed by the doctor is different from the dose recommended by the CONSORT dose calculator

Secondary objectives:

  • To evaluate the ease of using the new generation Gonal-f pen for subjects
  • To compare the Gonal-f dose finally used with the dose used during the previous treatment cycles (if this data is available)
  • To put a figure to the total duration of the treatment, total quantity of gonadotropins taken and the number of clinical pregnancies
  • In case of use of the CONSORT calculator: to estimate cancellations due to poor response This observational study will be conducted in 8 fertility centers in Belgium and Luxembourg as per the current clinical practice conditions in force at each center. Each center will recruit approximately 30 subjects to reach a total of approximately 250 subjects. The maximum number of treatment cycles to be evaluated in this project will be 600 over a period of approximately 6 months.

The CONSORT dose calculator is made available to all the participating centers via a secure web site. Each investigator will receive a user identification and password to access the system. The investigator will then introduce the 4 individual variables of the subject (basal FSH, BMI, age and number of antral follicles [follicles ≥2mm - <11mm]) in the CONSORT calculator, which will determine an individualized dose of Gonal-f for this specific subject. If the investigator does not agree with the dose calculated by CONSORT and opts for another dosage, he/she may indicate it directly in the CRF (Case Report Form). In this case, the Gonal-f dose will be based on the investigator's advice in accordance with the clinical practice in force in the center.

Follicle development shall be monitored in accordance with the current clinical practice of the center with diagnostic ultrasound and/or estradiol (E2) dosage until the local criteria for the administration of the human chorionic gonadotropin (hCG) is reached. Human chorionic gonadotropin will be administered in accordance with the current clinical practice of the center to reach final oocyte maturation. The date of administration of the hCG (Ovitrelle) will be indicated in the CRF.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 1, 2014
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 August 28, 2014