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

Aalborg University Hospital

Status: Not yet enrolling

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

Treatments: Other: magnetic resonance imaging (MRI)

Study type: Observational

Funder types: Other

Identifiers

NCT06471140

FET-PE-2024

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

75 participants in 3 patient groups

IVF-pregnancy achieved following modified natural FET cycle, autologous embryo transfer

Description:

One corpus luteum, control group, autologous embryo transfer

Treatment:

Other: magnetic resonance imaging (MRI)

IVF-pregnancy achieved following programmed FET cycle, autologous embryo transfer

Description:

No corpus luteum, study group, autologous embryo transfer

Treatment:

Other: magnetic resonance imaging (MRI)

IVF-pregnancy achieved following egg donation in a FET cycle

Description:

One corpus luteum or no corpus luteum, study group, donor egg recipient.

Treatment:

Other: magnetic resonance imaging (MRI)