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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Drug: rFSH drug dose Drug: "Standard" rFSH dose Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study
Study Start Date : September 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008
Arms and Interventions
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Arm Intervention/treatment
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).
 Drug: rFSH drug dose
"Individual" rFSH dose (50, 75 or 100 IU rFSH/day)
Active Comparator: "Standard" rFSH dose
"Standard" dose of rFSH
 Drug: "Standard" rFSH dose
"Standard" rFSH dose was 75 IU/day


Outcome Measures
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Primary Outcome Measures :
  1. Number of mature follicles in the study and control group.

Secondary Outcome Measures :
  1. Number of cycles where the rFSH dose is changed.
  2. Number of cycles cancelled or converted to in vitro fertilisation.
  3. Pregnancy rate. [ Time Frame: October 2008 ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374634


Locations
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Denmark
The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet
Copenhagen East, Denmark, 2100
Sponsors and Collaborators
Nina la Cour Freiesleben
Investigators
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Study Director: Anders N Andersen, Professor,MD The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nina la Cour Freiesleben, MD PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00374634    
Other Study ID Numbers: indvFSH2006
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: October 3, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Infertility