IVFNCT06471140
Maternal Cardiovascular Adaption to Pregnancy in IVF Patients Following Frozen Embryo Transfer (FET)
An observational study of IVF and Frozen Embryo Transfer (FET), run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Aim of the study is to explore the effect of a lacking corpus luteum on maternal cardiovascular and metabolic adaption to pregnancy by the use of magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF, Frozen Embryo Transfer (FET), Cardiovascular Adaption
- What is being tested?
- magnetic resonance imaging (MRI)
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2025to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: IVF-patients from The Fertility Unit Aalborg University Hospital and The Fertility Clinic, Skive Regional Hospital, Denmark.
Who may be able to join
- Autologous embryo transfer in programmed FET-cycle or modified-natural FET-cycle or
- Planned donor egg transfer in programmed FET-cycle or modified-natural FET-cycle
- Age < 40 years
- BMI < 35
- Primary diagnosis being unexplained infertility, male infertility or tubal factor
- Singleton blastocyst transfer
Who cannot join
- PCOS
- Essential hypertension
- Diabetes Mellitus (type 1 or 2)
- Known cardiac disease
- Antiphospholipid syndrome, Lupus erythematosus, rheumatoid disease
- Preelampsia, gestational hypertension, gestational diabetes or severe intrauterine growth restriction (IUGR) in any previous pregnancy
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- Smoking
- Multiple pregnancy
- Severe claustrophobia or any other contraindications to MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MRI Evaluation of Maternal Cardiovascular Response to Pregnancy in IVF Women Following Autologous Natural Cycle FET, Programmed FET and After Donor Embryo Transfer
Aim of the study is to explore the effect of a lacking corpus luteum on maternal cardiovascular and metabolic adaption to pregnancy by the use of magnetic resonance imaging (MRI).
Read the detailed description
The use of programmed frozen embryo transfer cycle (FET) in IVF women is associated with an increased risk of obstetric complications (pregnancy-induced hypertension, preeclampsia, postpartum hemorrhage and placenta accreta) compared to FET in natural cycle.
The lack of corpus luteum in programmed cycles and the subsequent absence of circulating vasoactive substances may lead to an impaired cardio-vascular adaption to pregnancy and thereby an increased risk of pregnancy-induced hypertension and preeclampsia.
The cardiovascular and metabolic adaption to pregnancy is evaluated throughout pregnancy by use of Magnetic Resonance Imaging (MRI) as well as non-invasive measurements by use of elastography and seismocardiography.
Patients are screened for preeclampsia throughout pregnancy with measurements of blood pressure, urine samples as well as blood samples.
- Conditions
- IVF, Frozen Embryo Transfer (FET), Cardiovascular Adaption, Magnetic Resonance Imaging (MRI), Preeclampsia
- Being tested
- magnetic resonance imaging (MRI)
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging (MRI)Other
Also called Elastography, Seismocardiography
MRI performed three times during pregnancy and 6 months postpartum
| Study group | Role | What they receive |
|---|---|---|
| IVF-pregnancy achieved following modified natural FET cycle, autologous embryo transfer | One corpus luteum, control group, autologous embryo transfer Receives: Other: magnetic resonance imaging (MRI) | |
| IVF-pregnancy achieved following programmed FET cycle, autologous embryo transfer | No corpus luteum, study group, autologous embryo transfer Receives: Other: magnetic resonance imaging (MRI) | |
| IVF-pregnancy achieved following egg donation in a FET cycle | One corpus luteum or no corpus luteum, study group, donor egg recipient. Receives: Other: magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal cardiovascular adaption to pregnancy
Measured: From early pregnancy to six months postpartum
Maternal metabolic adaption to pregnancy
Measured: From early pregnancy to six months postpartum
Placental function and fetal oxygenation estimated by longitudinal T2* weighted placental and fetal MRI
Measured: From early pregnancy to six months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Mar 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Viborg, Skive
- Responsible party
- Principal investigator, Lise Haaber Thomsen, Aalborg University Hospital
- Investigators
- Lise H Thomsen, MD, PhD, Study chair, Department of Obstetrics and Gynecology, Aalborg University Hospital, DenmarkAnne N Sørensen, MD, PhD, Study chair, Department of Obstetrics and Gynecology, Aalborg University Hospital, DenmarkUlrik Kesmodel, Professor, Study chair, The Fertility Unit, Department of Obstetrics and Gynecology, Aalborg University Hospital, DenmarkPeter Humaidan, Professor, Study chair, The Fertility Clinic, Department of Obstetrics and Gynecology, Skive Region Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471140
- Sponsor's protocol ID
- FET-PE-2024
- Status last verified
- May 2025
- First submitted
- 18 Jun 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Evaluation of Maternal Cardiovascular Response to Pregnancy in IVF Women Following Autologous Natural Cycle FET, Programmed FET and After Donor Embryo Transfer
- ClinicalTrials.gov ID
- NCT06471140
- Acronym / sponsor ID
- FET-PE-2024
- Conditions
- IVF, Frozen Embryo Transfer (FET), Cardiovascular Adaption, Magnetic Resonance Imaging (MRI), Preeclampsia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Regionshospitalet Viborg, Skive
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 24 Jun 2024 (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.
Aim of the study is to explore the effect of a lacking corpus luteum on maternal cardiovascular and metabolic adaption to pregnancy by the use of magnetic resonance imaging (MRI).
Detailed description
The use of programmed frozen embryo transfer cycle (FET) in IVF women is associated with an increased risk of obstetric complications (pregnancy-induced hypertension, preeclampsia, postpartum hemorrhage and placenta accreta) compared to FET in natural cycle.
The lack of corpus luteum in programmed cycles and the subsequent absence of circulating vasoactive substances may lead to an impaired cardio-vascular adaption to pregnancy and thereby an increased risk of pregnancy-induced hypertension and preeclampsia.
The cardiovascular and metabolic adaption to pregnancy is evaluated throughout pregnancy by use of Magnetic Resonance Imaging (MRI) as well as non-invasive measurements by use of elastography and seismocardiography.
Patients are screened for preeclampsia throughout pregnancy with measurements of blood pressure, urine samples as well as blood samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IVF-pregnancy achieved following modified natural FET cycle, autologous embryo transfer | – | Other: magnetic resonance imaging (MRI)One corpus luteum, control group, autologous embryo transfer |
| IVF-pregnancy achieved following programmed FET cycle, autologous embryo transfer | – | Other: magnetic resonance imaging (MRI)No corpus luteum, study group, autologous embryo transfer |
| IVF-pregnancy achieved following egg donation in a FET cycle | – | Other: magnetic resonance imaging (MRI)One corpus luteum or no corpus luteum, study group, donor egg recipient. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- IVF-patients from The Fertility Unit Aalborg University Hospital and The Fertility Clinic, Skive Regional Hospital, Denmark.
Key inclusion criteria (6 listed)
- Autologous embryo transfer in programmed FET-cycle or modified-natural FET-cycle or
- Planned donor egg transfer in programmed FET-cycle or modified-natural FET-cycle
- Age < 40 years
- BMI < 35
- Primary diagnosis being unexplained infertility, male infertility or tubal factor
Key exclusion criteria (9 listed)
- PCOS
- Essential hypertension
- Diabetes Mellitus (type 1 or 2)
- Known cardiac disease
- Antiphospholipid syndrome, Lupus erythematosus, rheumatoid disease
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 |
|---|---|---|
| magnetic resonance imaging (MRI)Also: Elastography, SeismocardiographyMRI performed three times during pregnancy and 6 months postpartum | Other | IVF-pregnancy achieved following egg donation in a FET cycle, IVF-pregnancy achieved following modified natural FET cycle, autologous embryo transfer, IVF-pregnancy achieved following programmed FET cycle, autologous embryo transfer |
Primary outcome
Maternal cardiovascular adaption to pregnancy
Time frame: From early pregnancy to six months postpartum
Maternal metabolic adaption to pregnancy
Time frame: From early pregnancy to six months postpartum
Placental function and fetal oxygenation estimated by longitudinal T2* weighted placental and fetal MRI
Time frame: From early pregnancy to six months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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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.
Lise H Thomsen, MD, PhD study chair
Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
Anne N Sørensen, MD, PhD study chair
Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
Ulrik Kesmodel, Professor study chair
The Fertility Unit, Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
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 IVF and Frozen Embryo Transfer (FET), run by Aalborg University 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 6 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 29 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Maternal cardiovascular adaption to pregnancy (time frame: From early pregnancy to six months postpartum). The study lists 3 primary outcomes in all. 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 29 May 2025.