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

NCT ID: NCT04359576

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Frozen Embryo Transfer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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FET

Estrogen/progesterone substituted and natural cycles

Primary and secondary hemostasis

Intervention Type DIAGNOSTIC_TEST

Focus on platelet aggregation, primary and secondary hemostasis parameters

Interventions

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Primary and secondary hemostasis

Focus on platelet aggregation, primary and secondary hemostasis parameters

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Horsens Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulla Breth Knudsen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Horsens Regional Hospital

Horsens, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TromboFET

Identifier Type: -

Identifier Source: org_study_id

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