Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Barusiban (FE 200440)
Treatment: Drugs - Placebo Comparator

Experimental: A. FE 200440 - Barusiban (FE 200440) Solution for Injection for Subcutaneous use

Placebo Comparator: B. Placebo - Placebo Solution for Injection for Subcutaneous use


Treatment: Drugs: Barusiban (FE 200440)


Treatment: Drugs: Placebo Comparator
Intervention code [1] 0 0
Treatment: Drugs
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
This trial investigates the effects of FE 200440 compared to placebo on implantation rate in
women undergoing IVF/ICSI treatment
Trial website
https://clinicaltrials.gov/ct2/show/NCT01723982
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01723982