Repeated Implantation FailureNCT01493440
Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure
A study testing atosiban in people with Repeated Implantation Failure, run by An Sinh Hospital at 1 site in Vietnam.
Trial summary
Atosiban, administered at embryo transfer, can improve the implantation rate and the clinical pregnancy rate in patients with repeated implantation failure undergoing IVF-ET (in-vitro fertilization and embryo transfer). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Repeated Implantation Failure
- What is being tested?
- atosiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteVietnam
- Study dates
- Mar 2011to Sep 2011
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- had repeated implantation failure
- have at least 1 good quality embryo for transfer
Who cannot join
- uterine abnormalities that could compromise the implantation process (e.g. fibroids, endometrial polyp, bicornuate uterus, adhesion of uterine cavity)
Trial locations and contacts
1 site in 1 country.
About this study
Atosiban, administered at embryo transfer, can improve the implantation rate and the clinical pregnancy rate in patients with repeated implantation failure undergoing IVF-ET (in-vitro fertilization and embryo transfer).
Read the detailed description
Atosiban is a mixed oxytocin and vasopressin V1A receptor antagonist.Combined antagonism at oxytocin and vasopressin V1A receptors reduces uterine contractions with a corresponding decrease in intrauterine production of prostaglandin F2alpha and improved uterine blood supply. These effects are of potential benefit for implantation support during IVF-ET cycles.
- Conditions
- Repeated Implantation Failure
- Being tested
- atosiban
- Keywords
- atosiban, clinical pregnancy, implantation rate, uterine contractility, IVF-ET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atosibanDrug
Also called Tractocile
Atosiban was administered as a 6.75mg IV bolus dose 30 minutes prior to embryo transfer followed by a 1-hour IV infusion at dose of 18 mg/h then a 2-hour IV infusion at 6 mg/h.
| Study group | Role | What they receive |
|---|---|---|
| Atosiban | Other | Not described Receives: Drug: atosiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
Measured: 5 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionSep 2011
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 Repeated 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- An Sinh Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vietnam National University
- Responsible party
- Principal investigator, Vuong Thi Ngoc Lan, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Lan TN Vuong, MD, Principal investigator, University of Medicine and Pharmacy of Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493440
- Sponsor's protocol ID
- IVFAS1103
- Status last verified
- Dec 2011
- First submitted
- 14 Dec 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Moraloglu O, Tonguc E, Var T, Zeyrek T, Batioglu S. Treatment with oxytocin antagonists before embryo transfer may increase implantation rates after IVF. Reprod Biomed Online. 2010 Sep;21(3):338-43. doi: 10.1016/j.rbmo.2010.04.009. Epub 2010 Apr 18.
PubMed 20638340
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure
- ClinicalTrials.gov ID
- NCT01493440
- Acronym / sponsor ID
- IVFAS1103
- Conditions
- Repeated Implantation Failure
- Keywords
- atosiban, clinical pregnancy, implantation rate, uterine contractility, IVF-ET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- An Sinh HospitalUniversity, hospital or other
- Collaborators
- Vietnam National University
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Dec 2011 (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.
Atosiban, administered at embryo transfer, can improve the implantation rate and the clinical pregnancy rate in patients with repeated implantation failure undergoing IVF-ET (in-vitro fertilization and embryo transfer).
Detailed description
Atosiban is a mixed oxytocin and vasopressin V1A receptor antagonist.Combined antagonism at oxytocin and vasopressin V1A receptors reduces uterine contractions with a corresponding decrease in intrauterine production of prostaglandin F2alpha and improved uterine blood supply. These effects are of potential benefit for implantation support during IVF-ET cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atosiban | Other | Drug: atosiban |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- had repeated implantation failure
- have at least 1 good quality embryo for transfer
Key exclusion criteria (1 listed)
- uterine abnormalities that could compromise the implantation process (e.g. fibroids, endometrial polyp, bicornuate uterus, adhesion of uterine cavity)
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 |
|---|---|---|
| atosibanAlso: TractocileAtosiban was administered as a 6.75mg IV bolus dose 30 minutes prior to embryo transfer followed by a 1-hour IV infusion at dose of 18 mg/h then a 2-hour IV infusion at 6 mg/h. | Drug | Atosiban |
Primary outcome
Clinical pregnancy
Time frame: 5 weeks after intervention
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 20 Dec 2011.
- Background: PubMed 20638340Moraloglu O, Tonguc E, Var T, Zeyrek T, Batioglu S. Treatment with oxytocin antagonists before embryo transfer may increase implantation rates after IVF. Reprod Biomed Online. 2010 Sep;21(3):338-43. doi: 10.1016/j.rbmo.2010.04.009. Epub 2010 Apr 18.
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Implantation Failure
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.
Lan TN Vuong, MD principal investigator
University of Medicine and Pharmacy of Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atosiban in people with Repeated Implantation Failure, run by An Sinh Hospital at 1 site in Vietnam.
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 20 Dec 2011. 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 Vietnam. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Clinical pregnancy (time frame: 5 weeks after intervention). 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 NCT01493440, 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 20 Dec 2011.