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

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ClinicalTrials.gov Identifier: NCT02610608
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
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 Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assistance Médicale à la Procréation et Risque Thrombotique
Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Evaluation of professional clinical practice for ovarian stimulation care [ Time Frame: Until 12 months followin ovarian stimulation ]

Secondary Outcome Measures :
  1. Arterial and/or venous thrombosis [ Time Frame: until 12 months following ovarian stimulation ]
  2. Risk factors for thrombosis [ Time Frame: until 12 months following ovarian stimulation ]

Other Outcome Measures:
  1. Incidence and risk factors for ovarian hyperstimuation syndrome [ Time Frame: until 12 months following ovarian stimulation ]

Biospecimen Retention:   Samples With DNA
One blood sample for each women particpating in the study


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing assisted reproductive thechnology
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610608


Contacts
Contact: Aurelien Delluc, MD, PhD 33298347336

Locations
France
Clinique Pasteur Recruiting
Brest, France, 29200
Contact: Jean-Jacques CHABAUD         
Medicentre- Clinique du Val d'Ouest Not yet recruiting
Ecully, France, 69130
Contact: Bernard Nicollet         
SELARL Gynecologia Not yet recruiting
Grenoble, France, 38000
Contact: Jean-Clément SAGE         
Hôpital Saint Joseph Not yet recruiting
Marseille, France, 13001
Contact: Betty ROSSIN         
CHU de Nice - Hôpital de l'Archet Not yet recruiting
Nice, France, 06202
Contact: Véronique Isnard         
AP-HP - Hôpital Bichat Not yet recruiting
Paris, France, 75018
Contact: Sylvie EPELBOIN         
Clinique Multualiste La sagesse Not yet recruiting
Rennes, France, 35000
Contact: Gérard PRIOU         
Clinique Mathilde Not yet recruiting
Rouen, France, 76100
Contact: Catherine Avril         
CHU de Strasbourg - CMCO Not yet recruiting
Schiltigheine, France, 67300
Contact: Jeanine OHL         
Sponsors and Collaborators
University Hospital, Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02610608     History of Changes
Other Study ID Numbers: AMPERT (RB13.160)
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Embolism and Thrombosis
Cardiovascular Diseases
Thrombosis
Embolism
Ovarian Hyperstimulation Syndrome
Vascular Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases