EFFects of Thrombophilia on the Outcomes of Assisted Repr... | NCT02407730

Studies
EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

NCT02407730

Sponsor

G. d'Annunzio University

Status

Completed

Last Update Posted

Aug 8, 2019Actual

Enrollment

687Actual

Phase

Not provided

Conditions

Birth Rate
Embryo Implantation
Reproductive Techniques
Thrombophilia

Interventions

Not provided

Countries

Italy

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jul 2017Actual

Completion Date

May 2018Actual

First Submitted Date

Mar 20, 2015

First Submission Date that Met QC Criteria

Mar 30, 2015

First Posted Date

Apr 3, 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

Aug 7, 2019

Last Update Posted Date

Aug 8, 2019Actual

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

Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage and pregnancy complications. Thrombophilia could favor the development of thrombosis of the maternal vasculature and obstacle placentation. Some studies have suggested a role of thrombophilia in the failure of assisted reproductive techniques although this association has been recently questioned. The scope of this study is to evaluate the effect of thrombophilia on the implantation rate and live birth rate in women undergoing ART.

Design: prospective, observational study Primary end-point: live birth rate. Secondary end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks post-partum

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

687Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Live birth rate		Participants will be followed for the duration of the pregnancy, an expected average of 9 months

Secondary Outcomes

Measure	Description	Time Frame
implantation rate		Participants will be followed from the implantation to the ultrasonography to document the gestational sac, an expected average of 7 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women undergoing ART
age 18 years or older

Exclusion Criteria:

ongoing anticoagulant therapy
previous venous thromboembolism
no informed consent

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

All women 18 years or older undergoing ART

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcello Di Nisio	University G. D'Annunzio, Chieti, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universita degli Studi G. d'Annunzio Chieti e Pescara		Chieti		66100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D019851	Thrombophilia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided