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

NCT06471140 | Enrolling By Invitation DMC

• 1 other identifier: FET-PE-2024
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Maternal cardiovascular adaption to pregnancy

  From early pregnancy to six months postpartum

• Maternal metabolic 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

Study Arms (3)

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

One corpus luteum, control group, autologous embryo transfer

Other: magnetic resonance imaging (MRI)

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

No corpus luteum, study group, autologous embryo transfer

Other: magnetic resonance imaging (MRI)

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)

Interventions

magnetic resonance imaging (MRI) OTHER

MRI performed three times during pregnancy and 6 months postpartum

Also known as: Elastography, Seismocardiography

IVF-pregnancy achieved following egg donation in a FET cycle; IVF-pregnancy achieved following modified natural FET cycle, autologous embryo transfer; IVF-pregnancy achieved following programmed FET cycle, autologous embryo transfer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Regionshospitalet Viborg, Skive: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Lise H Thomsen, MD, PhD

  Department of Obstetrics and Gynecology, Aalborg University Hospital, Denmark

  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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Consultant

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

DK (1)