Medical Assistance for the Procreation and Risk of Thrombosis. (AMPERT)

July 8, 2020 updated by: University Hospital, Brest

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • Clinique Pasteur
      • Ecully, France, 69130
        • Medicentre- Clinique du Val d'Ouest
      • Grenoble, France, 38000
        • SELARL Gynecologia
      • Marseille, France, 13001
        • Hopital Saint Joseph
      • Nice, France, 06202
        • CHU de Nice - Hôpital de l'Archet
      • Paris, France, 75018
        • AP-HP - Hôpital Bichat
      • Rennes, France, 35000
        • Clinique Multualiste La sagesse
      • Rouen, France, 76100
        • Clinique Mathilde
      • Schiltigheine, France, 67300
        • CHU de Strasbourg - CMCO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing assisted reproductive thechnology

Description

Inclusion Criteria:

  • All women undergoing ovarian stimulation in order to receive in vitro fertilization

Exclusion Criteria:

  • Age<18 years
  • Women refusing to particpate in the study
  • No health coverage
  • Women under guardianship
  • Women receiving therapeutic doses of anticoagulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women undergoing ART
Observation of the incidence of venous and arterial thrombosis following ovarian stimulation
Other: ovarian stimulation
evaluation of clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of professional clinical practice for ovarian stimulation care
Time Frame: Until 12 months followin ovarian stimulation
Until 12 months followin ovarian stimulation

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial and/or venous thrombosis
Time Frame: until 12 months following ovarian stimulation
until 12 months following ovarian stimulation
Risk factors for thrombosis
Time Frame: until 12 months following ovarian stimulation
until 12 months following ovarian stimulation

Other Outcome Measures

Outcome Measure
Time Frame
Incidence and risk factors for ovarian hyperstimuation syndrome
Time Frame: until 12 months following ovarian stimulation
until 12 months following ovarian stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2016

Primary Completion (Actual)

November 20, 2016

Study Completion (Actual)

November 20, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMPERT (RB13.160)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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