Ovarian Hyperstimulation SyndromeAMPERTNCT02610608
Medical Assistance for the Procreation and Risk of Thrombosis.
An observational study of Ovarian Hyperstimulation Syndrome and Cardiovascular Diseases, run by University Hospital, Brest at 9 sites in France.
Trial summary
This study aims at evaluating clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation. Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and venous thrombosis in women undergoing assisted reproductive technology and 2)to identify the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome, Cardiovascular Diseases, Embolism and Thrombosis
- What is being tested?
- ovarian stimulation
- How many people
- 129 participants
- Where
- 9 sitesFrance
- Study dates
- 2 Feb 2016to 20 Nov 2016
- 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: Women undergoing assisted reproductive thechnology
Who may be able to join
- All women undergoing ovarian stimulation in order to receive in vitro fertilization
Who cannot join
- Age<18 years
- Women refusing to particpate in the study
- No health coverage
- Women under guardianship
- Women receiving therapeutic doses of anticoagulation
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Clinique Pasteur
Brest, 29200
Medicentre- Clinique du Val d'Ouest
Écully, 69130
SELARL Gynecologia
Grenoble, 38000
Hôpital Saint Joseph
Marseille, 13001
CHU de Nice - Hôpital de l'Archet
Nice, 06202
AP-HP - Hôpital Bichat
Paris, 75018
Clinique Multualiste La sagesse
Rennes, 35000
Clinique Mathilde
Rouen, 76100
CHU de Strasbourg - CMCO
Schiltigheine, 67300
About this study
Official title: Assistance Médicale à la Procréation et Risque Thrombotique
This study aims at evaluating clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation.
Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and venous thrombosis in women undergoing assisted reproductive technology and 2)to identify the incidence and risk factors for ovarian hyperstimulation syndrome in these women
Read the detailed description
All women undergoing an assisted reproductive tecnology in order to receive an in vitro fertilization in French centers will be included in the study. These women will be followed up until 12 months after ovarian stimulation if they get pregnant or until 3 months if the stimulation does not lead to pregnancy. Risk factors for thrombosis and ovarian hyperstimulation syndrome will be collected in each woman. At each visit, women will be asked whether arterial and/or venous thrombosis had occured.
- Being tested
- ovarian stimulation
- Medical subject headings
- Ovarian Hyperstimulation Syndrome, Cardiovascular Diseases, Embolism and Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovarian stimulationOther
evaluation of clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing ART | Observation of the incidence of venous and arterial thrombosis following ovarian stimulation Receives: Other: ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of professional clinical practice for ovarian stimulation care
Measured: Until 12 months followin ovarian stimulation
Secondary outcomes (2)
Arterial and/or venous thrombosis
Measured: until 12 months following ovarian stimulation
Risk factors for thrombosis
Measured: until 12 months following ovarian stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start2 Feb 2016
- Primary completion20 Nov 2016
- Study completion20 Nov 2016
Why it stopped: RECRUITMENT DIFFICULTIES
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610608
- Sponsor's protocol ID
- AMPERT (RB13.160)
- Acronym
- AMPERT
- Status last verified
- Jul 2020
- First submitted
- 18 Nov 2015
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistance Médicale à la Procréation et Risque Thrombotique
- ClinicalTrials.gov ID
- NCT02610608
- Acronym / sponsor ID
- AMPERT / AMPERT (RB13.160)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: RECRUITMENT DIFFICULTIES
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 20 Nov 2016 (actual)
- Study completion
- 20 Nov 2016 (actual)
- First posted
- 20 Nov 2015 (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 study aims at evaluating clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation.
Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and venous thrombosis in women undergoing assisted reproductive technology and 2)to identify the incidence and risk factors for ovarian hyperstimulation syndrome in these women
Detailed description
All women undergoing an assisted reproductive tecnology in order to receive an in vitro fertilization in French centers will be included in the study. These women will be followed up until 12 months after ovarian stimulation if they get pregnant or until 3 months if the stimulation does not lead to pregnancy. Risk factors for thrombosis and ovarian hyperstimulation syndrome will be collected in each woman. At each visit, women will be asked whether arterial and/or venous thrombosis had occured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing ART | – | Other: ovarian stimulationObservation of the incidence of venous and arterial thrombosis following ovarian stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing assisted reproductive thechnology
Key inclusion criteria (1 listed)
- All women undergoing ovarian stimulation in order to receive in vitro fertilization
Key exclusion criteria (5 listed)
- Age<18 years
- Women refusing to particpate in the study
- No health coverage
- Women under guardianship
- Women receiving therapeutic doses of anticoagulation
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 |
|---|---|---|
| ovarian stimulationevaluation of clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation | Other | Women undergoing ART |
Primary outcome
Evaluation of professional clinical practice for ovarian stimulation care
Time frame: Until 12 months followin ovarian stimulation
2 secondary outcomes
Arterial and/or venous thrombosis
Time frame: until 12 months following ovarian stimulation
Risk factors for thrombosis
Time frame: until 12 months following ovarian stimulation
Results and safety
The study was stopped early (reason given: RECRUITMENT DIFFICULTIES). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Hyperstimulation Syndrome and Cardiovascular Diseases, run by University Hospital, Brest at 9 sites 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 was stopped early (reason given: RECRUITMENT DIFFICULTIES). Results are not available in the source record.
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 professional clinical practice for ovarian stimulation care (time frame: Until 12 months followin ovarian stimulation). 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 10 Jul 2020.