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)
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Embolism
• Embolism and Thrombosis
• Ovarian Hyperstimulation Syndrome
• Thrombosis

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