Medical Assistance for the Procreation and Risk of Thromb... | NCT02610608

Studies
Medical Assistance for the Procreation and Risk of Thrombosis.

NCT02610608

Sponsor

University Hospital, Brest

Status

Terminated

Last Update Posted

Jul 10, 2020Actual

Enrollment

129Actual

Phase

Not provided

Conditions

Ovarian Hyperstimulation Syndrome
Cardiovascular Diseases
Embolism and Thrombosis

Interventions

ovarian stimulation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

RECRUITMENT DIFFICULTIES

Expanded Access Info

Start Date

Feb 2, 2016Actual

Primary Completion Date

Nov 20, 2016Actual

Completion Date

Nov 20, 2016Actual

First Submitted Date

Nov 18, 2015

First Submission Date that Met QC Criteria

Nov 18, 2015

First Posted Date

Nov 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2020

Last Update Posted Date

Jul 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women undergoing ART		Observation of the incidence of venous and arterial thrombosis following ovarian stimulation	Other: ovarian stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ovarian stimulation	Other	evaluation of clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation	Women undergoing ART

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of professional clinical practice for ovarian stimulation care		Until 12 months followin ovarian stimulation

Secondary Outcomes

Measure	Description	Time Frame
Arterial and/or venous thrombosis		until 12 months following ovarian stimulation
Risk factors for thrombosis		until 12 months following ovarian stimulation

Other Outcomes

Measure	Description	Time Frame
Incidence and risk factors for ovarian hyperstimuation syndrome		until 12 months following ovarian stimulation

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women undergoing assisted reproductive thechnology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Pasteur		Brest		29200	France
Medicentre- Clinique du Val d'Ouest

Condition Browse Module

MeSH Terms

ID	Term
D016471	Ovarian Hyperstimulation Syndrome
D002318	Cardiovascular Diseases
D016769	Embolism and Thrombosis

Ancestor Terms

ID	Term
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010062	Ovulation Induction

Ancestor Terms

ID	Term
D027724	Reproductive Techniques, Assisted
D012099	Reproductive Techniques
D013812	Therapeutics
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided