Arteriovenous MalformationsMAVUFERTNCT03656211
Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation
An observational study of Arteriovenous Malformations, run by Rennes University Hospital at 1 site in France.
Trial summary
Uterine arteriovenous malformations (UAVM) are short circuits between systemic arterial and venous networks within the uterus. They are congenital or acquired (in the course of an endo-uterine gesture such as curettage or interventions such as caesareans or myomectomies). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Arteriovenous Malformations
- What is being tested?
- Telephone interview
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2017to 10 Oct 2017
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All the patients having a diagnosis of UAVM posed between January 1st, 2000 and March 30th, 2017, and confirmed by an imaging examination carried out at the Rennes University Hospital.
Who may be able to join
- Major patient
- Diagnosis of UAVM, symptomatic or not, between January 1st, 2000 and March 30th, 2017 confirmed by imagery performed at the Rennes University Hospital
- Not against her participation in research
Who cannot join
- Minor patient at the time of diagnosis
- congenital UAVM
- Uterine malformation
- Patient under legal protection (guardianship, curatorship, safeguard of justice).
Trial locations and contacts
1 site in 1 country.
About this study
Uterine arteriovenous malformations (UAVM) are short circuits between systemic arterial and venous networks within the uterus. They are congenital or acquired (in the course of an endo-uterine gesture such as curettage or interventions such as caesareans or myomectomies).
They can be manifested by severe metrorrhagia that can go as far as to put the patient's vital prognosis at risk.
Read more
There are no recommendations for the management of UAVM since this pathology is rare and therefore series are performed with few cases. If some of these UAVM disappear spontaneously after a therapeutic abstention, when the clinical context allows it, in case of symptomatic UAVM, a selective embolization with arteriography is often carried out to postpone the hysterectomy of hemostasis.
There are also more marginal management options such as Gonadotropin-Releasing Hormone agonists, methotrexate or curettage that are decided on a case by case basis depending on the symptoms and protocols of each medical team.
Regarding subsequent fertility and pregnancy outcomes after conservative treatment, the number of studies is even lower.
- Conditions
- Arteriovenous Malformations
- Being tested
- Telephone interview
- Keywords
- Uterine AVM
- Medical subject headings
- Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone interviewOther
Patients are contacted by telephone to know the history of the disease since the diagnosis of UAVM and the impact of management on fertility.
All medical data related to the care and necessary for the study are collected from the medical file the participation of the patients is limited to a telephone interview.
| Study group | Role | What they receive |
|---|---|---|
| Patients with UAVM | All patients who have been diagnosed with UAVM (symptomatic or non-symptomatic) between January 1, 2000 and March 30, 2017, and confirmed by an imaging examination.
Telephone interview Receives: Other: Telephone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of fertility
The telephone interview seeks to assess fertility for all patients diagnosed with symptomatic or non-symptomatic UAVM regardless of initial management.
Measured: At the time of inclusion
Secondary outcomes (4)
Pregnancy outcomes after UAVM
The telephone interview allows to evaluate pregnancy outcomes after diagnosis of UAVM regardless of initial management, in terms of live birth (full term or preterm birth), stillbirth, spontaneous abortion, and induced abortion.
Measured: At the time of inclusion
Term of delivery after UAVM
The telephone interview allows to evaluate the term of delivery after diagnosis of UAVM regardless of initial management
Measured: At the time of inclusion
Side effects of treatments for UAVM
The telephone interview allows to inventory the side effects of treatments
Measured: At the time of inclusion
Complications of treatments for UAVM
The telephone interview allows to evaluate the complications of treatments
Measured: At the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start2 Oct 2017
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous MalformationsStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krystel NYANGOH-TIMOH, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656211
- Sponsor's protocol ID
- 35RC17_3026
- Other IDs
- 2017-A01760-53
- Acronym
- MAVUFERT
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation
- ClinicalTrials.gov ID
- NCT03656211
- Acronym / sponsor ID
- MAVUFERT / 35RC17_3026
- Conditions
- Arteriovenous Malformations
- Keywords
- Uterine AVM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 4 Sep 2018 (actual)
- 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.
Uterine arteriovenous malformations (UAVM) are short circuits between systemic arterial and venous networks within the uterus. They are congenital or acquired (in the course of an endo-uterine gesture such as curettage or interventions such as caesareans or myomectomies).
They can be manifested by severe metrorrhagia that can go as far as to put the patient's vital prognosis at risk.
There are no recommendations for the management of UAVM since this pathology is rare and therefore series are performed with few cases. If some of these UAVM disappear spontaneously after a therapeutic abstention, when the clinical context allows it, in case of symptomatic UAVM, a selective embolization with arteriography is often carried out to postpone the hysterectomy of hemostasis.
There are also more marginal management options such as Gonadotropin-Releasing Hormone agonists, methotrexate or curettage that are decided on a case by case basis depending on the symptoms and protocols of each medical team.
Regarding subsequent fertility and pregnancy outcomes after conservative treatment, the number of studies is even lower.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with UAVM | – | Other: Telephone interviewAll patients who have been diagnosed with UAVM (symptomatic or non-symptomatic) between January 1, 2000 and March 30, 2017, and confirmed by an imaging examination. Telephone interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients having a diagnosis of UAVM posed between January 1st, 2000 and March 30th, 2017, and confirmed by an imaging examination carried out at the Rennes University Hospital.
Key inclusion criteria (3 listed)
- Major patient
- Diagnosis of UAVM, symptomatic or not, between January 1st, 2000 and March 30th, 2017 confirmed by imagery performed at the Rennes University Hospital
- Not against her participation in research
Key exclusion criteria (4 listed)
- Minor patient at the time of diagnosis
- congenital UAVM
- Uterine malformation
- Patient under legal protection (guardianship, curatorship, safeguard of justice).
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 |
|---|---|---|
| Telephone interviewPatients are contacted by telephone to know the history of the disease since the diagnosis of UAVM and the impact of management on fertility. All medical data related to the care and necessary for the study are collected from the medical file the participation of the patients is limited to a telephone interview. | Other | Patients with UAVM |
Primary outcome
Evaluation of fertility
Time frame: At the time of inclusion
The telephone interview seeks to assess fertility for all patients diagnosed with symptomatic or non-symptomatic UAVM regardless of initial management.
4 secondary outcomes
Pregnancy outcomes after UAVM
Time frame: At the time of inclusion
Term of delivery after UAVM
Time frame: At the time of inclusion
Side effects of treatments for UAVM
Time frame: At the time of inclusion
Complications of treatments for UAVM
Time frame: At the time of inclusion
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 4 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Krystel NYANGOH-TIMOH principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Malformations, run by Rennes University Hospital at 1 site in France.
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 3 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 4 Sep 2018. 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 France. 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?
Evaluation of fertility (time frame: At the time of inclusion). 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 4 Sep 2018.