A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment
NCT ID: NCT02309671
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2014-12-31
2016-09-30
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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FE 999049 6 µg
FE 999049
FE 999049 9 µg
FE 999049
FE 999049 12 µg
FE 999049
FOLLISTIM 150 IU
follitropin beta
follitropin beta
Interventions
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FE 999049
follitropin beta
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women eligible for IVF and/or ICSI treatment
* Women aged 20-39 years
* Women with body mass index (BMI) of 17.5-32.0 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
20 Years
39 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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Investigational site (there may be other sites in this country)
Tokyo, , Japan
Countries
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References
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Ishihara O, Klein BM, Arce JC; Japanese Follitropin Delta Phase 2 Trial Group. Randomized, assessor-blind, antimullerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta. Fertil Steril. 2021 Jun;115(6):1478-1486. doi: 10.1016/j.fertnstert.2020.10.059. Epub 2020 Dec 4.
Other Identifiers
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000124
Identifier Type: -
Identifier Source: org_study_id