Frozen Embryo TransferTromboFETNCT04359576
Frozen-thawed Embryo Transfers and Hormone Substitution on Thrombotic Risk Markers
An observational study of Frozen Embryo Transfer, run by Horsens Hospital at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Frozen Embryo Transfer
- What is being tested?
- Primary and secondary hemostasis
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2019to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: Healthy women receiving FET
Who may be able to join
- Women receiving FET with or without estrogen/progesterone substitution
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Frozen Embryo Transfer
- Being tested
- Primary and secondary hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary and secondary hemostasisDiagnostic test
Focus on platelet aggregation, primary and secondary hemostasis parameters
| Study group | Role | What they receive |
|---|---|---|
| FET | Estrogen/progesterone substituted and natural cycles Receives: Diagnostic Test: Primary and secondary hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
coagulation
Primary and secondary hemostasis parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Aug 2019
- Primary completionMar 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen Embryo TransferStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horsens Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Ulla Breth Knudsen, Horsens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359576
- Sponsor's protocol ID
- TromboFET
- Acronym
- TromboFET
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Frozen-thawed Embryo Transfers and Hormone Substitution on Thrombotic Risk Markers
- ClinicalTrials.gov ID
- NCT04359576
- Acronym / sponsor ID
- TromboFET / TromboFET
- Conditions
- Frozen Embryo Transfer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Horsens HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FET | – | Diagnostic Test: Primary and secondary hemostasisEstrogen/progesterone substituted and natural cycles |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Healthy women receiving FET
Key inclusion criteria (1 listed)
- Women receiving FET with or without estrogen/progesterone substitution
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary and secondary hemostasisFocus on platelet aggregation, primary and secondary hemostasis parameters | Diagnostic test | FET |
Primary outcome
coagulation
Time frame: 1 year
Primary and secondary hemostasis parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frozen Embryo Transfer, run by Horsens Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coagulation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.