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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01075854 |
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Date of registration:
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24/02/2010 |
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Primary sponsor: |
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Public title:
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An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)
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Scientific title:
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A Prospective, Multi-center, Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to IVF/ICSI |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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1539 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01075854 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI
treatment cycle will be eligible for this study
Exclusion Criteria:
- Subjects who have hypersensitivity to follitropin alfa, FSH or to any of the
excipients
- Subjects with tumors of the hypothalamus and pituitary gland
- Ovarian enlargement or cyst not due to polycystic ovarian disease
- Gynecological hemorrhages of unknown etiology
- Ovarian, uterine or mammary carcinoma
- Primary ovarian failure
- Malformations of sexual organs incompatible with pregnancy
- Fibroid tumors of the uterus incompatible with pregnancy
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Multifollicular Stimulation
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Intervention(s)
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Drug: Gonal-F (Follitropin alfa)
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Primary Outcome(s)
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Efficacy
[Time Frame: Start of treatment to confirmation of pregnancy]
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Secondary Outcome(s)
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Efficacy, Safety and Convenience
[Time Frame: Start of treatment to confirmation of pregnancy]
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Secondary ID(s)
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EMR 700623_507
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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