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NCT02610608 Clinical Trial

Medical Assistance for the Procreation and Risk of Thrombosis.

Cardiovascular Diseases Clinical Trial

— AMPERT  

Official title:
Assistance Médicale à la Procréation et Risque Thrombotique

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02610608
Other study ID # AMPERT (RB13.160)
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 2, 2016
Est. completion date November 20, 2016

Study information
Verified date July 2020
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 incidence and risk factors for ovarian hyperstimulation syndrome in these women

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.

Recruitment information / eligibility
Status Terminated
Enrollment 129
Est. completion date November 20, 2016
Est. primary completion date November 20, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• ovarian stimulation
evaluation of clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation

Locations
Country Name City State
France Clinique Pasteur Brest
France Medicentre- Clinique du Val d'Ouest Ecully
France SELARL Gynecologia Grenoble
France Hôpital Saint Joseph Marseille
France CHU de Nice - Hôpital de l'Archet Nice
France AP-HP - Hôpital Bichat Paris
France Clinique Multualiste La sagesse Rennes
France Clinique Mathilde Rouen
France CHU de Strasbourg - CMCO Schiltigheine

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Other Incidence and risk factors for ovarian hyperstimuation syndrome until 12 months following ovarian stimulation
Primary Evaluation of professional clinical practice for ovarian stimulation care Until 12 months followin ovarian stimulation
Secondary Arterial and/or venous thrombosis until 12 months following ovarian stimulation
Secondary Risk factors for thrombosis until 12 months following ovarian stimulation
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