- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04359576
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
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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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