Actively Recruiting

Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID06334003

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

Led by Rigshospitalet, Denmark · Updated on 2024-11-25

600

Participants Needed

3

Research Sites

30 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

H

Herlev Hospital

Collaborating Sponsor

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

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 3 locations

1

Fertility Clinic, Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark, 2100

Actively Recruiting

2

Department of Fetalmedicin, Herlev Hospital

Copenhagen, Denmark

Actively Recruiting

3

Dept. of Paediatric and Adolescent Medicine, Herlev Hospital

Copenhagen, Denmark

Not Yet Recruiting

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Research Team

M

Maria L Vestager, MD

A

Anna Sophie Lebech Kjær, MD

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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Frequently Asked Questions

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Published Research Related To This Trial

Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART): a prospective cohort study.

Anna Sophie Lebech Kjaer, Maria Linander Vestager, Elisabeth Blixenkrone-Møller...

https://pubmed.ncbi.nlm.nih.gov/40957860