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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00374634 |
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Date of registration:
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08/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination
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Scientific title:
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Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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234 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00374634 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Anders N Andersen, Professor,MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark |
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Key inclusion & exclusion criteria
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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
Age minimum:
25 Years
Age maximum:
39 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Infertility
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Intervention(s)
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Drug: rFSH drug dose
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Drug: "Standard" rFSH dose
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Primary Outcome(s)
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Number of mature follicles in the study and control group.
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Secondary Outcome(s)
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Number of cycles where the rFSH dose is changed.
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Pregnancy rate.
[Time Frame: October 2008]
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Number of cycles cancelled or converted to in vitro fertilisation.
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Secondary ID(s)
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indvFSH2006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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