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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01723982




Registration number
NCT01723982
Ethics application status
Date submitted
5/10/2012
Date registered
8/11/2012
Date last updated
16/06/2015

Titles & IDs
Public title
Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions
Scientific 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
Secondary ID [1] 0 0
2012-001622-10
Secondary ID [2] 0 0
000048
Universal Trial Number (UTN)
Trial acronym
BASIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: A. FE 200440 - Barusiban (FE 200440) Solution for Injection for Subcutaneous use

Placebo comparator: B. Placebo - Placebo Solution for Injection for Subcutaneous use
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ongoing implantation rate
Timepoint [1] 0 0
10-11 weeks after embryo transfer
Secondary outcome [1] 0 0
Ongoing pregnancy rate
Timepoint [1] 0 0
10-11 weeks after transfer
Secondary outcome [2] 0 0
Implantation rate
Timepoint [2] 0 0
5-6 weeks after transfer
Secondary outcome [3] 0 0
Clinical pregnancy rate
Timepoint [3] 0 0
5-6 weeks after transfer
Secondary outcome [4] 0 0
Positive Beta Human Chorionic Gonadotrophin (ßhCG) rate
Timepoint [4] 0 0
13-15 days after transfer
Secondary outcome [5] 0 0
Serum barusiban concentration at the expected tmax
Timepoint [5] 0 0
30 min after 2nd IMP administration
Secondary outcome [6] 0 0
Frequency and intensity of adverse events
Timepoint [6] 0 0
Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer
Secondary outcome [7] 0 0
Frequency and intensity of injection site reactions
Timepoint [7] 0 0
Immediately and 30 min after each administration of IMP

Eligibility
Key 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 ßhCG 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
Minimum age
18 Years
Maximum age
37 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
256
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Fertility Centre - Westmead
Recruitment hospital [2] 0 0
Monash IVF - Clayton
Recruitment hospital [3] 0 0
Melbourne IVF - Melbourne
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Prague
Country [5] 0 0
Poland
State/province [5] 0 0
Warsaw
Country [6] 0 0
Spain
State/province [6] 0 0
Alicante
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid
Country [9] 0 0
Spain
State/province [9] 0 0
Sevilla
Country [10] 0 0
Spain
State/province [10] 0 0
Valencia
Country [11] 0 0
Spain
State/province [11] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ferring Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Development Support
Address 0 0
Ferring Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01723982