NCT03660007

Brief Summary

In vitro fertilization (IVF) is associated with an increased risk of venous thromboembolism and in particular pulmonary embolism during the first trimester. It is not known whether this increased risk of pulmonary embolism is present both after fresh and frozen embryo transfer. Objective: To assess whether the risk of pulmonary embolism and venous thromboembolism during the first trimester of IVF pregnancies is associated with both fresh and frozen embryo transfer. A population-based cohort study with linked data from nationwide registries on women in Sweden giving birth to their first child 1992-2012

Trial Health

100
On Track

Trial Health Score

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

Enrollment
902,891

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1992

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1992

Completed
21 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

21 years

First QC Date

August 30, 2018

Last Update Submit

September 5, 2018

Conditions

Keywords

In vitro fertilizationAssisted Reproductive TechniquesPulmonary embolismVenous ThromboembolismPregnancy

Outcome Measures

Primary Outcomes (1)

  • First incident pulmonary embolism

    Pulmonary embolism during the period from start of pregnancy until pregnancy day 90

    Estimated start of pregnancy until day 90

Secondary Outcomes (1)

  • First incident venous thromboembolism

    Estimated start of pregnancy until day 90

Study Arms (3)

Fresh embryo transfer

This exposure is an IVF pregnancy with fresh embryo transfer performed directly after ovarian stimulation

Procedure: Fresh or frozen embryo transfer IVF

Frozen embryo transfer

This exposure is an IVF pregnancy with frozen embryo transfer, which was thawed and transferred in a later, non-stimulated cycle

Procedure: Fresh or frozen embryo transfer IVF

Natural pregnancy

Spontaneous pregnancy without IVF

Interventions

Fresh embryo transferFrozen embryo transfer

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All Swedish women who had given birth at the age of 15-50 years to a first child from the 1st of January 1992 until the 31st of December 2012 .

You may qualify if:

  • Women who had given birth to a first child

You may not qualify if:

  • Women with previous pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Olausson N, Discacciati A, Nyman AI, Lundberg F, Hovatta O, Westerlund E, Wallen HN, Mobarrez F, Bottai M, Ekbom A, Henriksson P. Incidence of pulmonary and venous thromboembolism in pregnancies after in vitro fertilization with fresh respectively frozen-thawed embryo transfer: Nationwide cohort study. J Thromb Haemost. 2020 Aug;18(8):1965-1973. doi: 10.1111/jth.14840. Epub 2020 May 11.

MeSH Terms

Conditions

Pulmonary EmbolismVenous Thromboembolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolism

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 6, 2018

Study Start

January 1, 1992

Primary Completion

December 31, 2012

Study Completion

December 31, 2014

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share