InfertilityPhase 2BASICNCT01723982
Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions
A Phase 2 study testing Barusiban (FE 200440) in people with Infertility, run by Ferring Pharmaceuticals at 14 sites in 6 countries.
Trial summary
This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Barusiban (FE 200440)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 14 sitesin 6 countries
- Study dates
- Nov 2012to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Spain6 sites
IVI Alicante
Alicante
Dexeus
Barcelona
IVI Madrid
Madrid
IVI Sevilla
Seville
IVI Valencia
Valencia
IVI Zaragoza
Zaragoza
Australia3 sites
Monash IVF
Clayton, Victoria
Melbourne IVF
Melbourne, Victoria
Westmead Fertility Centre
Westmead, New South Wales
About this study
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
This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment
- Conditions
- Infertility
- Being tested
- Barusiban (FE 200440), Placebo Comparator
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barusiban (FE 200440)Drug
Placebo ComparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| A. FE 200440 | Experimental | Barusiban (FE 200440) Solution for Injection for Subcutaneous use Receives: Drug: Barusiban (FE 200440) |
| B. Placebo | Placebo comparator | Placebo Solution for Injection for Subcutaneous use Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing implantation rate
Measured: 10-11 weeks after embryo transfer
Secondary outcomes (7)
Ongoing pregnancy rate
Measured: 10-11 weeks after transfer
Implantation rate
Measured: 5-6 weeks after transfer
Clinical pregnancy rate
Measured: 5-6 weeks after transfer
Positive Beta Human Chorionic Gonadotrophin (βhCG) rate
Measured: 13-15 days after transfer
Serum barusiban concentration at the expected tmax
Measured: 30 min after 2nd IMP administration
Frequency and intensity of adverse events
Measured: Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer
Frequency and intensity of injection site reactions
Measured: Immediately and 30 min after each administration of IMP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723982
- Sponsor's protocol ID
- 000048
- Other IDs
- 2012-001622-10
- Acronym
- BASIC
- Status last verified
- Jun 2015
- First submitted
- 5 Oct 2012
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01723982
- Acronym / sponsor ID
- BASIC / 000048
- Conditions
- Infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. FE 200440 | Experimental | Drug: Barusiban (FE 200440)Barusiban (FE 200440) Solution for Injection for Subcutaneous use |
| B. Placebo | Placebo comparator | Drug: Placebo ComparatorPlacebo Solution for Injection for Subcutaneous use |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barusiban (FE 200440) | Drug | A. FE 200440 |
| Placebo Comparator | Drug | B. Placebo |
Primary outcome
Ongoing implantation rate
Time frame: 10-11 weeks after embryo transfer
7 secondary outcomes
Ongoing pregnancy rate
Time frame: 10-11 weeks after transfer
Implantation rate
Time frame: 5-6 weeks after transfer
Clinical pregnancy rate
Time frame: 5-6 weeks after transfer
Positive Beta Human Chorionic Gonadotrophin (βhCG) rate
Time frame: 13-15 days after transfer
Serum barusiban concentration at the expected tmax
Time frame: 30 min after 2nd IMP administration
Frequency and intensity of adverse events
Time frame: Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer
Frequency and intensity of injection site reactions
Time frame: Immediately and 30 min after each administration of IMP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Barusiban (FE 200440) in people with Infertility, run by Ferring Pharmaceuticals at 14 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, Australia, Belgium, Canada, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing implantation rate (time frame: 10-11 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.