Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions
NCT ID: NCT01723982
Last Updated: 2015-06-16
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
256 participants
INTERVENTIONAL
2012-11-30
2015-05-31
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
DOUBLE
Study Groups
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A. FE 200440
Barusiban (FE 200440) Solution for Injection for Subcutaneous use
Barusiban (FE 200440)
B. Placebo
Placebo Solution for Injection for Subcutaneous use
Placebo Comparator
Interventions
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Barusiban (FE 200440)
Placebo Comparator
Eligibility Criteria
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Inclusion Criteria
* Women who have undergone 2-4 previous fresh in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) cycles that all resulted in a negative βhCG test, despite transfer of at least one embryo/blastocyst of good quality
* Women who have in the current controlled ovarian stimulation cycle for IVF/ICSI followed the long Gonadotrophin Releasing Hormone (GnRH) agonist or GnRH antagonist protocol, received hCG for triggering of final follicular maturation and have undergone oocyte retrieval for IVF/ICSI with the purpose of fresh transfer
* Retrieval of at least 6 oocytes in the current controlled ovarian stimulation cycle
* Subjects should have at least one embryo of good quality available for transfer on day 3, or at least one good quality blastocyst available for transfer on day 5
Exclusion Criteria
* Abnormal karyotype
* Uterine pathology or hydrosalpinx
* Diagnosed with acquired or congenital thrombophilia disease
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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Westmead Fertility Centre
Westmead, New South Wales, Australia
Monash IVF
Clayton, Victoria, Australia
Melbourne IVF
Melbourne, Victoria, Australia
UZ Brussel
Brussels, , Belgium
AZ Jan Palfijn Gent AV
Ghent, , Belgium
Clinique OVO
Montreal, Quebec, Canada
ICF CUBE
Prague, , Czechia
nOvum
Warsaw, , Poland
IVI Alicante
Alicante, , Spain
Dexeus
Barcelona, , Spain
IVI Madrid
Madrid, , Spain
IVI Sevilla
Seville, , Spain
IVI Valencia
Valencia, , Spain
IVI Zaragoza
Zaragoza, , Spain
Countries
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Other Identifiers
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2012-001622-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
000048
Identifier Type: -
Identifier Source: org_study_id
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