Barusiban Subcutaneously for Reducing Implantation Failur... | NCT01723982

Studies
Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

NCT01723982

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Jun 16, 2015Estimated

Enrollment

256Actual

Phase

Phase 2

Conditions

Infertility

Interventions

Barusiban (FE 200440)
Placebo Comparator

Countries

Australia
Belgium
Canada
Czechia
Poland
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-001622-10	EudraCT Number

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Oct 2014Actual

Completion Date

May 2015Actual

First Submitted Date

Oct 5, 2012

First Submission Date that Met QC Criteria

Nov 6, 2012

First Posted Date

Nov 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2015

Last Update Posted Date

Jun 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

256Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A. FE 200440	Experimental	Barusiban (FE 200440) Solution for Injection for Subcutaneous use	Drug: Barusiban (FE 200440)
B. Placebo	Placebo Comparator	Placebo Solution for Injection for Subcutaneous use	Drug: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Barusiban (FE 200440)	Drug		A. FE 200440
Placebo Comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing implantation rate		10-11 weeks after embryo transfer

Secondary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy rate		10-11 weeks after transfer
Implantation rate		5-6 weeks after transfer
Clinical pregnancy rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Westmead Fertility Centre		Westmead	New South Wales		Australia
Monash IVF

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases