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

• Conditions: Magnetic Resonance Imaging (MRI); Preeclampsia; IVF; Frozen Embryo Transfer (FET); Cardiovascular Adaption

• Registration Number: NCT06471140
• Lead Sponsor: Aalborg University Hospital

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.

Study Timeline

• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-24
• Study Start: 2025-03-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-29
• Primary Completion: 2027-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal cardiovascular adaption to pregnancy	From early pregnancy to six months postpartum
Placental function and fetal oxygenation estimated by longitudinal T2* weighted placental and fetal MRI	From early pregnancy to six months postpartum
Maternal metabolic adaption to pregnancy	From early pregnancy to six months postpartum

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark