Implantation FailurePhase 4NCT01673399
Oxytocin Antagonist in Patients With Repeated Failure of Implantation
A Phase 4 study testing Atosiban in people with Implantation Failure, run by AZ Jan Palfijn Gent at 1 site in Belgium.
Trial summary
In this study the investigators compare the usual way of embryo transfer (without medication) with an embryo transfer while administering oxytocine antagonist. This to improve implantation and increase the pregnancy rate. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Implantation Failure
- What is being tested?
- Atosiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2012to Feb 2015
- Phase
- Phase 4
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- IVF/ ICSI patients below 38 years
- 2e to 6e IVF-cycle
Who cannot join
- patients with endocrinological diseases or problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxytocin Antagonist in Patients With Repeated Failure of Implantation. A Prospective Randomized Placebo-controlled Double-blind Study.
In this study the investigators compare the usual way of embryo transfer (without medication) with an embryo transfer while administering oxytocine antagonist. This to improve implantation and increase the pregnancy rate.
- Conditions
- Implantation Failure
- Being tested
- Atosiban, placebo
- Keywords
- repeated implantation failure (RIF), atosiban, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtosibanDrug
Bolus atosiban 6.75mg + infusion atosiban 18mg/u during 3 hours. once administered starting 1 hour before embryotransfer.
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Atosiban | Active comparator | Patients receive a bolus injection of 6.75mg atosiban and following an atosibaninfusion at 18mg/u during 3 hours. Receives: Drug: Atosiban |
| placebo | Placebo comparator | Patients receive a placebo bolus injection (NaCl 0.9%)and an infusion of NaCl 0.9% during 3 hours Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
the number of patients that show a positive serum blood pregnancy test
Measured: 16 days from eggretrieval
Secondary outcomes (1)
pregnancy rate
The number of patients with an ongoing first trimester pregnancy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implantation FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Jan Palfijn Gent
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouw Hospital
- Responsible party
- Principal investigator, Dr. Decleer Wim, AZ Jan Palfijn Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673399
- Sponsor's protocol ID
- 2012-000278-49
- Status last verified
- Feb 2021
- First submitted
- 23 Aug 2012
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Craciunas L, Tsampras N, Kollmann M, Raine-Fenning N, Choudhary M. Oxytocin antagonists for assisted reproduction. Cochrane Database Syst Rev. 2021 Sep 1;9(9):CD012375. doi: 10.1002/14651858.CD012375.pub2.
PubMed 34467530
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Antagonist in Patients With Repeated Failure of Implantation. A Prospective Randomized Placebo-controlled Double-blind Study.
- ClinicalTrials.gov ID
- NCT01673399
- Acronym / sponsor ID
- 2012-000278-49
- Conditions
- Implantation Failure
- Keywords
- repeated implantation failure (RIF), atosiban, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- AZ Jan Palfijn GentUniversity, hospital or other
- Collaborators
- Onze Lieve Vrouw Hospital
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Aug 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.
In this study the investigators compare the usual way of embryo transfer (without medication) with an embryo transfer while administering oxytocine antagonist. This to improve implantation and increase the pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atosiban | Active comparator | Drug: AtosibanPatients receive a bolus injection of 6.75mg atosiban and following an atosibaninfusion at 18mg/u during 3 hours. |
| placebo | Placebo comparator | Drug: placeboPatients receive a placebo bolus injection (NaCl 0.9%)and an infusion of NaCl 0.9% during 3 hours |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- IVF/ ICSI patients below 38 years
- 2e to 6e IVF-cycle
Key exclusion criteria (1 listed)
- patients with endocrinological diseases or problems
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 |
|---|---|---|
| AtosibanBolus atosiban 6.75mg + infusion atosiban 18mg/u during 3 hours. once administered starting 1 hour before embryotransfer. | Drug | Atosiban |
| placebo | Drug | placebo |
Primary outcome
implantation rate
Time frame: 16 days from eggretrieval
the number of patients that show a positive serum blood pregnancy test
1 secondary outcome
pregnancy rate
Time frame: 12 weeks
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 2 Feb 2021.
- Derived from this study: PubMed 34467530Craciunas L, Tsampras N, Kollmann M, Raine-Fenning N, Choudhary M. Oxytocin antagonists for assisted reproduction. Cochrane Database Syst Rev. 2021 Sep 1;9(9):CD012375. doi: 10.1002/14651858.CD012375.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atosiban in people with Implantation Failure, run by AZ Jan Palfijn Gent at 1 site in Belgium.
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 2 inclusion and 1 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
implantation rate (time frame: 16 days from eggretrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01673399, which also lists 1 linked publication.
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 2 Feb 2021.