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Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00374634
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : October 3, 2011
Sponsor:
Information provided by (Responsible Party):
Nina la Cour Freiesleben, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE September 8, 2006
First Posted Date  ICMJE September 11, 2006
Last Update Posted Date October 3, 2011
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2006)
Number of mature follicles in the study and control group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
  • Number of cycles where the rFSH dose is changed.
  • Number of cycles cancelled or converted to in vitro fertilisation.
  • Pregnancy rate. [ Time Frame: October 2008 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2006)
  • Number of cycles where the rFSH dose is changed.
  • Number of cycles cancelled or converted to in vitro fertilisation.
  • Pregnancy rate.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination
Official Title  ICMJE Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study
Brief Summary The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given in individual doses, according to a nomogram we have constructed based on our results from a previous study, results in more patients maturing 2-3 follicles compared to standard dose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: rFSH drug dose
    "Individual" rFSH dose (50, 75 or 100 IU rFSH/day)
  • Drug: "Standard" rFSH dose
    "Standard" rFSH dose was 75 IU/day
Study Arms  ICMJE
  • Active Comparator: "Individual" or "standard" rFSH dose
    Patients were randomized to recieve "individual" (50, 75 or 100 IU/day) or "standard" (75 IU/day) rFSh dose. The individual dose was prescribed according to a dosage nomogram based on the patient's body weight (kg) and the total antral follicle count (Freiesleben NC et al., RBMOnline 2009;17:632-64).
    Intervention: Drug: rFSH drug dose
  • Active Comparator: "Standard" rFSH dose
    "Standard" dose of rFSH
    Intervention: Drug: "Standard" rFSH dose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2011)
234
Original Enrollment  ICMJE
 (submitted: September 8, 2006)
220
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 25-39 years
  • First stimulation with rFSH only
  • Indication for intrauterine insemination with standard rFSH starting dose
  • Regular menstrual bleeding with a cycle between 21-35 days
  • Two ovaries
  • Bilateral tuba patency
  • Semen analysis must be sufficient for insemination according to the diagnostic analysis.

Exclusion Criteria:

  • More than three former stimulated intrauterine insemination cycles
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00374634
Other Study ID Numbers  ICMJE indvFSH2006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nina la Cour Freiesleben, Rigshospitalet, Denmark
Study Sponsor  ICMJE Nina la Cour Freiesleben
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anders N Andersen, Professor,MD The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP