NCT01100333

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 31, 2014

Status Verified

January 1, 2013

Enrollment Period

3.2 years

First QC Date

February 24, 2010

Last Update Submit

July 30, 2014

Conditions

Infertility

Keywords

InfertilityReproductive technologies, Assistedr-hFSHGonal-f

Outcome Measures

Primary Outcomes (1)

  • Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator

    6 month

Secondary Outcomes (1)

  • Efficacy parameters

    6 month

Interventions

Recombinant human follicle stimulating hormone (r-hFSH)DRUG

Recombinant hFSH prescribed according to prescriber's judgement

Also known as: Gonal-f

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Subjects undergoing Assisted Reproductive Technologies (ART) receiving Gonal-f in Germany

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin Charitè Berlin, Schumann Straße 20/21

Berlin, State of Berlin, 101107, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood

MeSH Terms

Conditions

InfertilityHelping Behavior

Interventions

Glycoprotein Hormones, alpha Subunitfollitropin alfa

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesSocial BehaviorBehavior

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

  • W. Bilger

    Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 24, 2010

First Posted

April 8, 2010

Study Start

April 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 31, 2014

Record last verified: 2013-01

Locations

DE(1)