AMPERT: Medical Assistance for the Procreation and Risk of Thrombosis.

Sponsor

University Hospital, Brest (Other)

Overall Status

Terminated

CT.gov ID

NCT02610608

Collaborator

(none)

129

Enrollment

Locations

9.6

Actual Duration (Months)

14.3

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Ovarian Hyperstimulation Syndrome Cardiovascular Diseases Embolism and Thrombosis	Other: ovarian stimulation

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

Study Type:

Observational

Actual Enrollment :

129 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assistance Médicale à la Procréation et Risque Thrombotique

Actual Study Start Date :

Feb 2, 2016

Actual Primary Completion Date :

Nov 20, 2016

Actual Study Completion Date :

Nov 20, 2016

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Evaluation of professional clinical practice for ovarian stimulation care [Until 12 months followin ovarian stimulation]

Secondary Outcome Measures

Arterial and/or venous thrombosis [until 12 months following ovarian stimulation]
Risk factors for thrombosis [until 12 months following ovarian stimulation]

Other Outcome Measures

Incidence and risk factors for ovarian hyperstimuation syndrome [until 12 months following ovarian stimulation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Pasteur	Brest	France	29200
2	Medicentre- Clinique du Val d'Ouest	Ecully	France	69130
3	SELARL Gynecologia	Grenoble	France	38000
4	Hôpital Saint Joseph	Marseille	France	13001
5	CHU de Nice - Hôpital de l'Archet	Nice	France	06202
6	AP-HP - Hôpital Bichat	Paris	France	75018
7	Clinique Multualiste La sagesse	Rennes	France	35000
8	Clinique Mathilde	Rouen	France	76100
9	CHU de Strasbourg - CMCO	Schiltigheine	France	67300