A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
NCT ID: NCT01426386
Last Updated: 2020-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
265 participants
INTERVENTIONAL
2011-09-30
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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5.2 µg
FE 999049
6.9 µg
FE 999049
8.6 µg
FE 999049
10.3 µg
FE 999049
12.1 µg
FE 999049
11 µg FbM (150 IU)
Gonal - F
Interventions
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FE 999049
Gonal - F
Eligibility Criteria
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Inclusion Criteria
* 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 history of recurrent miscarriage
* Women with contraindications to controlled ovarian stimulation with gonadotropins
* Women with three or more controlled ovarian stimulation cycles
18 Years
37 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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UZ Brussel
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
ICF CUBE
Prague, , Czechia
Rigshospitalet
Copenhagen, , Denmark
IU Dexeus
Barcelona, , Spain
IVI Madrid
Madrid, , Spain
IVI Sevilla
Seville, , Spain
IVI Valencia
Valencia, , Spain
Countries
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References
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Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.
Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, Barri P, de Sutter P, Klein BM, Fauser BC. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40.e5. doi: 10.1016/j.fertnstert.2014.08.013. Epub 2014 Sep 23.
Other Identifiers
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2011-000633-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
000009
Identifier Type: -
Identifier Source: org_study_id