NCT01080729

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
Last Updated

July 2, 2014

Status Verified

October 1, 2011

Enrollment Period

1 year

First QC Date

March 3, 2010

Last Update Submit

July 1, 2014

Conditions

Multifollicular Stimulation

Keywords

Ovulation inductionOvarian Hyperstimulation SyndromeMultifollicular stimulationPregnancySperm injections, intracytoplasmicFertility

Outcome Measures

Primary Outcomes (1)

  • Comparison between the initial Gonal-f FbM dose prescribed by the doctor and the initial Gonal-f FbM dose recommended by the CONSORT calculator

    Before and after the treatement for 1 cycle over a period of 6 months

Secondary Outcomes (1)

  • Secondary variables

    Before and after the treatement for 1 cycle over a period of 6 months

Interventions

Recombinant-follicle stimulating hormone (r-FSH)DRUG

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).

Also known as: GONAL-f™

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Subjects simultaneously participating in an interventional study
  • Subjects following concomitant treatment with clomifene citrate
  • Subjects presenting one of the contraindications described in the SPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZNA Middelheim

Antwerp, Lindendreef 1, B-2020, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Serum

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Glycoprotein Hormones, alpha Subunitfollitropin alfa

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Chorionic GonadotropinGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsFollicle Stimulating HormoneGonadotropins, PituitaryLuteinizing HormonePituitary Hormones, AnteriorPituitary HormonesThyrotropinPlacental HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Medical Responsible

    Merck N.V.-S.A., Belgium

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 4, 2010

Study Start

February 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

July 2, 2014

Record last verified: 2011-10

Locations

BE(1)