Maternal Cardiovascular Adaption to Pregnancy in IVF Patients Following Frozen Embryo Transfer (FET)
NCT ID: NCT06471140
Last Updated: 2025-05-29
Study Results
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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ENROLLING_BY_INVITATION
75 participants
OBSERVATIONAL
2025-03-01
2028-08-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IVF-pregnancy achieved following modified natural FET cycle, autologous embryo transfer
One corpus luteum, control group, autologous embryo transfer
magnetic resonance imaging (MRI)
MRI performed three times during pregnancy and 6 months postpartum
IVF-pregnancy achieved following programmed FET cycle, autologous embryo transfer
No corpus luteum, study group, autologous embryo transfer
magnetic resonance imaging (MRI)
MRI performed three times during pregnancy and 6 months postpartum
IVF-pregnancy achieved following egg donation in a FET cycle
One corpus luteum or no corpus luteum, study group, donor egg recipient.
magnetic resonance imaging (MRI)
MRI performed three times during pregnancy and 6 months postpartum
Interventions
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magnetic resonance imaging (MRI)
MRI performed three times during pregnancy and 6 months postpartum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Smoking
* Multiple pregnancy
* Severe claustrophobia or any other contraindications to MRI
18 Years
40 Years
FEMALE
Yes
Sponsors
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Regionshospitalet Viborg, Skive
OTHER
Aalborg University Hospital
OTHER
Responsible Party
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Lise Haaber Thomsen
MD, Consultant
Principal Investigators
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Lise H Thomsen, MD, PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
Anne N Sørensen, MD, PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
Ulrik Kesmodel, Professor
Role: STUDY_CHAIR
The Fertility Unit, Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
Peter Humaidan, Professor
Role: STUDY_CHAIR
The Fertility Clinic, Department of Obstetrics and Gynecology, Skive Region Hospital, Denmark
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Countries
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Other Identifiers
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FET-PE-2024
Identifier Type: -
Identifier Source: org_study_id
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