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Maternal Cardiovascular Adaption to Pregnancy in IVF Patients Following Frozen Embryo Transfer (FET)

MRI Evaluation of Maternal Cardiovascular Response to Pregnancy in IVF Women Following Autologous Natural Cycle FET, Programmed FET and After Donor Embryo Transfer

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06471140
Enrollment
75
Registered
2024-06-24
Start date
2025-03-01
Completion date
2028-08-01
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Adaption, Frozen Embryo Transfer (FET), IVF, Magnetic Resonance Imaging (MRI), Preeclampsia

Brief 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).

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.

Interventions

OTHERmagnetic resonance imaging (MRI)

MRI performed three times during pregnancy and 6 months postpartum

Sponsors

Regionshospitalet Viborg, Skive
CollaboratorOTHER
Aalborg University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * Smoking * Multiple pregnancy * Severe claustrophobia or any other contraindications to MRI

Design outcomes

Primary

MeasureTime frame
Maternal cardiovascular adaption to pregnancyFrom early pregnancy to six months postpartum
Maternal metabolic adaption to pregnancyFrom early pregnancy to six months postpartum
Placental function and fetal oxygenation estimated by longitudinal T2* weighted placental and fetal MRIFrom early pregnancy to six months postpartum

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026