Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

NCT ID: NCT01723982

Last Updated: 2015-06-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-05-31

Brief Summary

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This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A. FE 200440

Barusiban (FE 200440) Solution for Injection for Subcutaneous use

Group Type EXPERIMENTAL

Barusiban (FE 200440)

Intervention Type DRUG

B. Placebo

Placebo Solution for Injection for Subcutaneous use

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Interventions

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Barusiban (FE 200440)

Intervention Type DRUG

Placebo Comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women aged 18-37 years
* 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

* A total of 6 or more controlled ovarian stimulation cycles for IVF/ICSI
* Abnormal karyotype
* Uterine pathology or hydrosalpinx
* Diagnosed with acquired or congenital thrombophilia disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Monash IVF

Clayton, Victoria, Australia

Site Status

Melbourne IVF

Melbourne, Victoria, Australia

Site Status

UZ Brussel

Brussels, , Belgium

Site Status

AZ Jan Palfijn Gent AV

Ghent, , Belgium

Site Status

Clinique OVO

Montreal, Quebec, Canada

Site Status

ICF CUBE

Prague, , Czechia

Site Status

nOvum

Warsaw, , Poland

Site Status

IVI Alicante

Alicante, , Spain

Site Status

Dexeus

Barcelona, , Spain

Site Status

IVI Madrid

Madrid, , Spain

Site Status

IVI Sevilla

Seville, , Spain

Site Status

IVI Valencia

Valencia, , Spain

Site Status

IVI Zaragoza

Zaragoza, , Spain

Site Status

Countries

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Australia Belgium Canada Czechia Poland Spain

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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