Clinical trial NCT06471140: Maternal Cardiovascular Adaption to Pregnancy in IVF Patients Following Frozen Embryo Transfer (FET)
Official title: MRI Evaluation of Maternal Cardiovascular Response to Pregnancy in IVF Women Following Autologous Natural Cycle FET, Programmed FET and After Donor Embryo Transfer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: IVF
Frozen Embryo Transfer (FET)
Cardiovascular Adaption
Magnetic Resonance Imaging (MRI)
Preeclampsia
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Viborg, Skive
First posted: 2024-06-24
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IVF-patients from The Fertility Unit Aalborg University Hospital and The Fertility Clinic, Skive Regional Hospital, Denmark.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal cardiovascular adaption to pregnancy
timeFrame: From early pregnancy to six months postpartum
measure: Maternal metabolic adaption to pregnancy
timeFrame: From early pregnancy to six months postpartum
measure: Placental function and fetal oxygenation estimated by longitudinal T2* weighted placental and fetal MRI
timeFrame: From early pregnancy to six months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
name: Lise H Thomsen, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
name: Anne N Sørensen, MD, PhD
role: STUDY_CHAIR
affiliation: The Fertility Unit, Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark
name: Ulrik Kesmodel, Professor
role: STUDY_CHAIR
affiliation: The Fertility Clinic, Department of Obstetrics and Gynecology, Skive Region Hospital, Denmark
name: Peter Humaidan, Professor
role: STUDY_CHAIR
References: