Medical Assistance for the Procreation and Risk of Thrombosis.

Terminated

• Conditions: Ovarian Hyperstimulation Syndrome; Embolism and Thrombosis; Cardiovascular Diseases
• Interventions: Other: ovarian stimulation

• Registration Number: NCT02610608
• Lead Sponsor: University Hospital, Brest

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

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 Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Study Start: 2016-02-02
• Primary Completion: 2016-11-20
• Study Completion: 2016-11-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 129

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing ART	ovarian stimulation	Observation of the incidence of venous and arterial thrombosis following ovarian stimulation

Primary Outcome Measures

Name	Time	Method
Evaluation of professional clinical practice for ovarian stimulation care	Until 12 months followin ovarian stimulation

Secondary Outcome Measures

Name	Time	Method
Arterial and/or venous thrombosis	until 12 months following ovarian stimulation
Risk factors for thrombosis	until 12 months following ovarian stimulation

Trial Locations

Locations (9)

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

Clinique Multualiste La sagesse; 🇫🇷 Rennes, France

Clinique Mathilde; 🇫🇷 Rouen, France

CHU de Strasbourg - CMCO; 🇫🇷 Schiltigheine, France

AP-HP - Hôpital Bichat; 🇫🇷 Paris, France