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

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

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

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Barusiban (FE 200440); Drug: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia
      • Westmead Fertility Centre
  • Victoria
    • Clayton, Victoria, Australia
      • Monash IVF
    • Melbourne, Victoria, Australia
      • Melbourne IVF
• Belgium
  • Brussels, Belgium
    • UZ Brussel
  • Gent, Belgium
    • AZ Jan Palfijn Gent AV
• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Clinique OVO
• Czech Republic
  • Prague, Czech Republic
    • ICF CUBE
• Poland
  • Warsaw, Poland
    • NOVUM
• Spain
  • Alicante, Spain
    • IVI Alicante
  • Barcelona, Spain
    • Dexeus
  • Madrid, Spain
    • IVI Madrid
  • Sevilla, Spain
    • IVI Sevilla
  • Valencia, Spain
    • IVI Valencia
  • Zaragoza, Spain
    • IVI Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A. FE 200440; Barusiban (FE 200440) Solution for Injection for Subcutaneous use	Drug: Barusiban (FE 200440)
Placebo Comparator: B. Placebo; Placebo Solution for Injection for Subcutaneous use	Drug: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Ongoing pregnancy rate	10-11 weeks after transfer
Implantation rate	5-6 weeks after transfer
Clinical pregnancy rate	5-6 weeks after transfer
Positive Beta Human Chorionic Gonadotrophin (βhCG) rate	13-15 days after transfer
Serum barusiban concentration at the expected tmax	30 min after 2nd IMP administration
Frequency and intensity of adverse events	Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer
Frequency and intensity of injection site reactions	Immediately and 30 min after each administration of IMP

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: October 5, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 8, 2012

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 15, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 000048; 2012-001622-10 (EudraCT Number)