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Enrolling by Invitation

NCT Number: NCT06471140

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

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).

Enrolling by Invitation

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

magnetic resonance imaging (MRI)

Other

MRI performed three times during pregnancy and 6 months postpartum

Other names: Elastography, Seismocardiography

Primary outcomes

  1. Maternal cardiovascular adaption to pregnancy

    Time frame: From early pregnancy to six months postpartum

  2. Maternal metabolic adaption to pregnancy

    Time frame: From early pregnancy to six months postpartum

  3. Placental function and fetal oxygenation estimated by longitudinal T2* weighted placental and fetal MRI

    Time frame: From early pregnancy to six months postpartum

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Regionshospitalet Viborg, Skive

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 24, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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