search
Back to results

Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions (BASIC)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Barusiban (FE 200440)
Placebo Comparator
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Fertility Centre
  • Monash IVF
  • Melbourne IVF
  • UZ Brussel
  • AZ Jan Palfijn Gent AV
  • Clinique OVO
  • ICF CUBE
  • nOvum
  • IVI Alicante
  • Dexeus
  • IVI Madrid
  • IVI Sevilla
  • IVI Valencia
  • IVI Zaragoza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A. FE 200440

B. Placebo

Arm Description

Barusiban (FE 200440) Solution for Injection for Subcutaneous use

Placebo Solution for Injection for Subcutaneous use

Outcomes

Primary Outcome Measures

Ongoing implantation rate

Secondary Outcome Measures

Ongoing pregnancy rate
Implantation rate
Clinical pregnancy rate
Positive Beta Human Chorionic Gonadotrophin (βhCG) rate
Serum barusiban concentration at the expected tmax
Frequency and intensity of adverse events
Frequency and intensity of injection site reactions

Full Information

First Posted
October 5, 2012
Last Updated
June 15, 2015
Sponsor
Ferring Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01723982
Brief Title
Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions
Acronym
BASIC
Official Title
A Randomised, Placebo-controlled, Double-blind, Parallel Groups, Multinational, Multicentre Trial Assessing the Effect of Barusiban Administered Subcutaneously on the Day of Transfer on Implantation and Pregnancy Rates in IVF/ICSI Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A. FE 200440
Arm Type
Experimental
Arm Description
Barusiban (FE 200440) Solution for Injection for Subcutaneous use
Arm Title
B. Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Solution for Injection for Subcutaneous use
Intervention Type
Drug
Intervention Name(s)
Barusiban (FE 200440)
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Primary Outcome Measure Information:
Title
Ongoing implantation rate
Time Frame
10-11 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Ongoing pregnancy rate
Time Frame
10-11 weeks after transfer
Title
Implantation rate
Time Frame
5-6 weeks after transfer
Title
Clinical pregnancy rate
Time Frame
5-6 weeks after transfer
Title
Positive Beta Human Chorionic Gonadotrophin (βhCG) rate
Time Frame
13-15 days after transfer
Title
Serum barusiban concentration at the expected tmax
Time Frame
30 min after 2nd IMP administration
Title
Frequency and intensity of adverse events
Time Frame
Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer
Title
Frequency and intensity of injection site reactions
Time Frame
Immediately and 30 min after each administration of IMP

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Westmead Fertility Centre
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Monash IVF
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Melbourne IVF
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
UZ Brussel
City
Brussels
Country
Belgium
Facility Name
AZ Jan Palfijn Gent AV
City
Gent
Country
Belgium
Facility Name
Clinique OVO
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
ICF CUBE
City
Prague
Country
Czech Republic
Facility Name
nOvum
City
Warsaw
Country
Poland
Facility Name
IVI Alicante
City
Alicante
Country
Spain
Facility Name
Dexeus
City
Barcelona
Country
Spain
Facility Name
IVI Madrid
City
Madrid
Country
Spain
Facility Name
IVI Sevilla
City
Sevilla
Country
Spain
Facility Name
IVI Valencia
City
Valencia
Country
Spain
Facility Name
IVI Zaragoza
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

We'll reach out to this number within 24 hrs