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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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29 October 2012 |
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Main ID: |
NCT01426386 |
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Date of registration:
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30/08/2011 |
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Primary sponsor: |
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Public title:
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A Dose-response Trial Using rFSH FE999049 in Women Undergoing IVF/ICSI Treatment
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Scientific title:
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A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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265 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01426386 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Belgium
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Czech Republic
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Denmark
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Spain
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Contacts
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Name:
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Clinical Development Support |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ferring Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women diagnosed with tubal infertility, unexplained infertility, infertility related
to endometriosis stage I/II or with partners diagnosed with male factor infertility
- Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm
injection) treatment
- Women aged 18-37 years
- Women with body mass index (BMI) of 18.5-32.0 kg/m2
Exclusion Criteria:
- Women with polycystic ovary syndrome (PCOS) associated with anovulation,
endometriosis stage III/IV
- Women with history of recurrent miscarriage
- Women with contraindications to controlled ovarian stimulation with gonadotropins
- Women with three or more controlled ovarian stimulation cycles
Age minimum:
18 Years
Age maximum:
37 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: FE999049
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Drug: Gonal - F
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Primary Outcome(s)
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Number of oocytes retrieved
[Time Frame: End of stimulation (10-15 days)]
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Secondary Outcome(s)
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Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing
[Time Frame: 5 days (from oocyte retrieval until embryo transfer)]
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Endocrine profile measured by circulating levels of hormones
[Time Frame: Up to 16 days]
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Frequency and intensity of adverse events
[Time Frame: From signing ICF (informed consent form) until end of trial visit = 8-9 weeks]
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Number and size of follicles during stimulations
[Time Frame: Up to 16 days]
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Successful pregnancy rate
[Time Frame: 5-6 weeks]
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Total IMP (investigational medicinal product) dose administered measured from first until last dose (end of stimulation)
[Time Frame: Up to 16 days]
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Secondary ID(s)
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000009
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2011-000633-36
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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