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Incidence of Pulmonary and Venous Thromboembolism in IVF Pregnancies After Fresh and Frozen Embryo Transfer

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ClinicalTrials.gov Identifier: NCT03660007
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Henriksson, Karolinska Institutet

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


Condition or disease Intervention/treatment
Assisted Reproductive Techniques Pregnancy Pulmonary Embolism Venous Thromboembolism Fresh Embryo Transfer Frozen Embryo Transfer Procedure: Fresh or frozen embryo transfer IVF

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 902891 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Months
Official Title: Association of Pulmonary and Venous Thromboembolism in IVF Pregnancies After Fresh and Frozen Embryo Transfer: a Population-based Cohort Study
Actual Study Start Date : January 1, 1992
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. First incident pulmonary embolism [ Time Frame: Estimated start of pregnancy until day 90 ]
    Pulmonary embolism during the period from start of pregnancy until pregnancy day 90


Secondary Outcome Measures :
  1. First incident venous thromboembolism [ Time Frame: Estimated start of pregnancy until day 90 ]
    Venous thromboembolism during the period from start of pregnancy until pregnancy day 90



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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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 .
Criteria

Inclusion Criteria:

  • Women who had given birth to a first child

Exclusion Criteria:

  • Women with previous pregnancies

Additional Information:

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Responsible Party: Peter Henriksson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03660007     History of Changes
Other Study ID Numbers: Fresh or Frozen IVF
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter Henriksson, Karolinska Institutet:
In vitro fertilization
Assisted Reproductive Techniques
Pulmonary embolism
Venous Thromboembolism
Pregnancy

Additional relevant MeSH terms:
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Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases