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

May 23, 2025 updated by: Lise Haaber Thomsen, Aalborg University Hospital

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

IVF-patients from The Fertility Unit Aalborg University Hospital and The Fertility Clinic, Skive Regional Hospital, Denmark.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IVF-pregnancy achieved following modified natural FET cycle, autologous embryo transfer
One corpus luteum, control group, autologous embryo transfer
Other: magnetic resonance imaging (MRI)
MRI performed three times during pregnancy and 6 months postpartum
Other Names:
  • Elastography
  • Seismocardiography
IVF-pregnancy achieved following programmed FET cycle, autologous embryo transfer
No corpus luteum, study group, autologous embryo transfer
Other: magnetic resonance imaging (MRI)
MRI performed three times during pregnancy and 6 months postpartum
Other Names:
  • Elastography
  • Seismocardiography
IVF-pregnancy achieved following egg donation in a FET cycle
One corpus luteum or no corpus luteum, study group, donor egg recipient.
Other: magnetic resonance imaging (MRI)
MRI performed three times during pregnancy and 6 months postpartum
Other Names:
  • Elastography
  • Seismocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maternal cardiovascular adaption to pregnancy
Time Frame: From early pregnancy to six months postpartum
From early pregnancy to six months postpartum
Maternal metabolic adaption to pregnancy
Time Frame: From early pregnancy to six months postpartum
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
From early pregnancy to six months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Collaborators

Regionshospitalet Viborg, Skive

Investigators

  • Study Chair: Anne N Sørensen, MD, PhD, Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
  • Study Chair: Ulrik Kesmodel, Professor, The Fertility Unit, Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
  • Study Chair: Peter Humaidan, Professor, The Fertility Clinic, Department of Obstetrics and Gynecology, Skive Region Hospital, Denmark
  • Study Chair: Lise H Thomsen, MD, PhD, Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FET-PE-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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