Study of Heart and Metabolic Health in Mothers, Babies, and Placentas After Assisted Reproductive Technology Compared to Natural Conception
Led by Rigshospitalet, Denmark · Updated on 2024-11-25
600
Participants Needed
3
Research Sites
30 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the long-term health effects of pregnancies achieved through assisted reproductive technology ART, focusing on frozen embryo transfer FET, fresh embryo transfer fresh ET, and natural conception NC. The study aims to understand how maternal cardiometabolic profiles, fetal growth, and placental function differ among these groups, and how these factors influence metabolic and endocrine health in the offspring. It also explores genetic and epigenetic patterns in placenta, fetus, and parents, as well as telomere length and hormone levels in young children.
This observational study follows a cohort of pregnant women from three groups those who conceived by FET, fresh ET, and NC. Pregnant women will undergo three examinations during pregnancy, including blood sampling for growth factors and metabolic biomarkers, fetal ultrasound, and doppler ultrasound. Placental tissue will be collected at delivery for genetic and epigenetic analysis. Newborns will have blood samples taken and undergo DEXA scans within two weeks of birth to assess body composition and metabolic markers.
Participants will be followed from early pregnancy through birth and early childhood. Assessments include maternal blood tests once each trimester, detailed fetal growth monitoring, and newborn evaluations at around 2.5 months. Long-term outcomes such as epigenetic changes, reproductive hormone levels, and telomere length will be assessed up to 3 years of age. The study collects clinical data and health records to evaluate links between ART procedures and offspring health, aiming to identify potential biomarkers and targets for preventing obesity and metabolic diseases.
CONDITIONS
Brief Title
Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology
Research Team
M
Maria L Vestager, MD
A
Anna Sophie Lebech Kjær, MD
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Pregnant women who received fertility treatment at Rigshospitalet or Herlev Hospital (FET and fresh ET groups) or are scheduled for prenatal ultrasounds at these hospitals (NC group)
Inclusion must occur before the routine ultrasound scan in the first trimester
Pregnant women aged between 18 and 40 years
Expecting a single baby (not twins or more)
You will not qualify if you...
Maternal pregestational diabetes type 1 or 2
Pregnancies with more than one fetus (non-singleton pregnancies)
Maternal pregestational BMI greater than 35 kg/m2
Severe maternal co-morbidity
Use of oocyte donation
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit before the routine first trimester ultrasound scan
Monitoring
Duration - Throughout pregnancy (first, second, and third trimesters)
Participants undergo examinations during pregnancy including blood sampling, fetal biometry, and Doppler ultrasound to assess maternal growth factors, metabolic profile, and fetal growth.
3 visits during pregnancy (one in each trimester)
Diagnostic Evaluation
Duration - At birth
At delivery, placental tissue is collected and analyzed for growth factors and epigenetic alterations in a subpopulation of participants.
1 visit at delivery for placental collection (subpopulation only)
Monitoring
Duration - Within 2 weeks after birth
Newborns are examined within two weeks of birth including blood sampling and DEXA scans to evaluate body composition and metabolic profile.
1 visit for newborn examination
Long-term Monitoring
Duration - Up to 3 years after birth
Participants are followed for epigenetic markers, reproductive function, and telomere length assessments in children to evaluate long-term outcomes.
Follow-up assessments at 2, 2.5, and 3 years of age
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Study of Heart and Metabolic Health in Mothers, Babies, and Placentas After Assisted Reproductive Technology Compared to Natural Conception