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BASIC: Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01723982
Collaborator
(none)
256
Enrollment
14
Locations
2
Arms
29.9
Duration (Months)
18.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Barusiban (FE 200440)
  • Drug: Placebo Comparator
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
256 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Ongoing implantation rate [10-11 weeks after embryo transfer]

Secondary Outcome Measures

  1. Ongoing pregnancy rate [10-11 weeks after transfer]

  2. Implantation rate [5-6 weeks after transfer]

  3. Clinical pregnancy rate [5-6 weeks after transfer]

  4. Positive Beta Human Chorionic Gonadotrophin (βhCG) rate [13-15 days after transfer]

  5. Serum barusiban concentration at the expected tmax [30 min after 2nd IMP administration]

  6. Frequency and intensity of adverse events [Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer]

  7. Frequency and intensity of injection site reactions [Immediately and 30 min after each administration of IMP]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 37 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Westmead Fertility Centre Westmead New South Wales Australia
2 Monash IVF Clayton Victoria Australia
3 Melbourne IVF Melbourne Victoria Australia
4 UZ Brussel Brussels Belgium
5 AZ Jan Palfijn Gent AV Gent Belgium
6 Clinique OVO Montréal Quebec Canada
7 ICF CUBE Prague Czech Republic
8 nOvum Warsaw Poland
9 IVI Alicante Alicante Spain
10 Dexeus Barcelona Spain
11 IVI Madrid Madrid Spain
12 IVI Sevilla Sevilla Spain
13 IVI Valencia Valencia Spain
14 IVI Zaragoza Zaragoza Spain

Sponsors and Collaborators

  • Ferring Pharmaceuticals

Investigators

  • Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01723982
Other Study ID Numbers:
  • 000048
  • 2012-001622-10
First Posted:
Nov 8, 2012
Last Update Posted:
Jun 16, 2015
Last Verified:
Jun 1, 2015
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of Jun 16, 2015