Frozen-thawed Embryo Transfers and Hormone Substitution on Thrombotic Risk Markers (TromboFET)

April 18, 2021 updated by: Ulla Breth Knudsen, Horsens Hospital

Impact of Frozen-thawed Embryo Transfers and Hormone Substitution on Thrombotic Risk Markers

The study focus on the impact of estrogen/progesterone substitution during artificial cycle frozen embryo transfer (AC-FET) in women undertaking assisted reproductive technology treatment (ART).

Study Overview

Status

Active, not recruiting

Detailed Description

The aim is to investigate whether the coagulation is activated in women undergoing estrogen/progesterone substitution during artificial cycle frozen embryo transfer (AC-FET) in assisted reproductive technology treatment (ART). An activation of the coagulation might induce an increased thromboembolic risk in these women. Thus, the present study may lead to improvement of the current treatment protocol for women receiving AC-FET and ultimately prevent thromboembolic complications for woman in fertility treatment.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Horsens, Denmark, 8700
        • Horsens Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy women receiving FET

Description

Inclusion Criteria:

  • Women receiving FET with or without estrogen/progesterone substitution

Exclusion Criteria:

  • Known bleeding disorder
  • Indication for thromboprophylaxis during ART treatment
  • Treatment with anti-platelet medication including non-steroid-anti-inflammatory drugs (NSAIDs) within the last week
  • Donor recipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FET
Estrogen/progesterone substituted and natural cycles
Focus on platelet aggregation, primary and secondary hemostasis parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coagulation
Time Frame: 1 year
Primary and secondary hemostasis parameters
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 18, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TromboFET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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