Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology

NCT06334003 · tracked via the Priya Life Science Denmark tracker

Sponsor

Copenhagen University Hospital, Rigshospitalet

Phase

Observational

Started

2024-05-17

Last updated

2024-11-25

Condition(s) studied

ARTIVFChildren, OnlyCardiovascular Disease Other

Study summary

The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women, biological fathers/partners and offspring from pregnancies achieved by frozen embryo transfer (FET), fresh-embryo transfer (fresh ET) and naturally conceived (NC) to investigate maternal cardiometabolic profiles, fetal growth patterns and placental function during pregnancy as well as metabolic and endocrine health in the offspring. Additionally, the aim is to explore genetic and epigenetic patterns in placenta, fetus and parents. As secondary objectives, the investigator group will examine telomere length and minipuberty hormones in children born after FET, fresh-ET and NC.

Eligibility

Sex

ALL

Min age

18 Years

Max age

40 Years

Healthy volunteers

Accepted

Inclusion Criteria: Pregnant women who have either had fertility treatment at Rigshospitalet or Herlev Hospital (FET and fresh ET groups) or are scheduled for prenatal ultrasounds at Rigshospitalet or Herlev Hospital (NC group) will be screened for eligibility. Inclusion must happen before their routine ultrasound scan in 1. trimester. Exclusion Criteria: * Maternal pregestational diabetes type 1 or 2 * Non-singleton pregnancies * Maternal pregestational BMI \> 35 kg/m2 * Severe maternal co-morbidity * Oocyte donation

Primary outcome measure(s)

Offspring body composition — Assessed at 2,5 months of age
Total fat mass (in gram) assessed by air displacement plethysmography (PEA POD).
Maternal cardiometabolic profile — One times during each trimester
Fetal growth patterns determined by ultrasound

Trial sites (3)

Facility	City	Region	Status
Fertility Clinic, Rigshospitalet, Copenhagen University Hospital	Copenhagen	Denmark	Recruiting
Department of Fetalmedicin, Herlev Hospital	Copenhagen	Denmark	Recruiting
Dept. of Paediatric and Adolescent Medicine, Herlev Hospital	Copenhagen	Denmark	Not Yet Recruiting

Other trials for the same condition

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Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes Recruiting

Vestibular and Postural Function in Children Suspected of Balance Disorders Recruiting

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

Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06334003 on ClinicalTrials.gov ↗ ← All trials in Denmark