NCT01524393

Brief Summary

Occurrence of venous thromboembolism during in Vitro Fertilization (IVF) pregnancies has been reported in numerous case reports and in two small consecutive series. The incidence of venous thromboembolism (VTE) after IVF has been claimed to be comparable to the incidence of VTE during normal pregnancy. No information exists concerning pulmonary embolism (PE). The aim is to estimate and compare the risk of both PE and VTE during the the different phases of pregnancy after IVF to that in age and period matched control women. The investigators will use the Swedish National Health Registers to estimate the risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140,458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1990

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1990

Completed
18.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

18.9 years

First QC Date

January 28, 2012

Last Update Submit

February 1, 2012

Conditions

Keywords

Assisted Reproductive TechniquesPregnancyPulmonary EmbolismVenous Thromboembolism

Study Arms (1)

IVF pregnancy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All mothers who had given birth to a child.

You may qualify if:

  • Exposed women:
  • All mothers who had given birth to a child as a result of IVF will be retrieved from the Swedish Medical Birth Register (MBR) at the National Board of Health and Welfare.
  • Unexposed women:
  • Each IVF woman will be matched with up to 5 unexposed women from the MBR by calendar year of delivery ±2 years and maternal age ±1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (3)

  • Chan WS, Dixon ME. The "ART" of thromboembolism: a review of assisted reproductive technology and thromboembolic complications. Thromb Res. 2008;121(6):713-26. doi: 10.1016/j.thromres.2007.05.023. Epub 2007 Jul 30.

    PMID: 17659766BACKGROUND
  • Mara M, Koryntova D, Rezabek K, Kapral A, Drbohlav P, Jirsova S, Zivny J. [Thromboembolic complications in patients undergoing in vitro fertilization: retrospective clinical study]. Ceska Gynekol. 2004 Jul;69(4):312-6. Czech.

    PMID: 15369253BACKGROUND
  • Henriksson P, Westerlund E, Wallen H, Brandt L, Hovatta O, Ekbom A. Incidence of pulmonary and venous thromboembolism in pregnancies after in vitro fertilisation: cross sectional study. BMJ. 2013 Jan 15;346:e8632. doi: 10.1136/bmj.e8632.

MeSH Terms

Conditions

Pulmonary EmbolismVenous Thromboembolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolism

Study Officials

  • Anders Ekbom, Professor

    Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden

    STUDY CHAIR
  • Peter Henriksson, Professor

    Division of Cardiovascular Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR
  • Outi Hovatta, Professor

    Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2012

First Posted

February 2, 2012

Study Start

January 1, 1990

Primary Completion

December 1, 2008

Study Completion

December 1, 2010

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations