NCT03719703

Brief Summary

The purpose of this trial is to investigate the metabolic and cardiovascular health in children aged 6-8 years born after in-vitro fertilization with frozen embryo transfer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
606

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

October 23, 2018

Last Update Submit

March 29, 2023

Conditions

ARTIVFCardiovascular Risk FactorHypertensionChildren

Keywords

Frozen embryo transfer; cardiovascular; metabolic; IVF

Outcome Measures

Primary Outcomes (2)

  • BMI

    We want to investigate BMI status among FET children as hight BMI is known to be a risk factor for cardiovascular disease

    At admission

  • Cardiovascular risk profiling with cardiac MRI

    Determination of markers of cardiovascular risk by cardiac MRI of left and right site of the heart, distensibility of pulmonary artery and aorta and the amount of epi- and pericardial fat in children conceived by FET compared to natural conceived children.

    At admission

Secondary Outcomes (4)

  • HOMA-IR

    At admission

  • DXA scan

    At admission

  • Epigenetics

    After admission

  • Blood pressure

    at admission

Study Arms (3)

Case 1

Children conceived by frozen embryo transfer

Case 2

Children conceived by fresh embryo transfer

Control

Naturally conceived children

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will be recruited from the Capital Region of Denmark.

You may qualify if:

  • Children born after frozen embryo transfer, fresh embryo transfer and natural conception
  • Age 6 - 8 years

You may not qualify if:

  • The mother of childrens with diabetes mellitus type I or II
  • Gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertilitetsklinikken 4071

Copenhagen, Denmark

Location

Related Publications (5)

  • Gronlund EW, Kjaer ASL, Asserhoj LL, Mizrak I, Clausen TD, Madsen PL, Pinborg A, Jensen RB. Bone mineralization in children aged 7-10 years born after ART with frozen and fresh embryo transfer. Hum Reprod Open. 2025 Sep 11;2025(4):hoaf055. doi: 10.1093/hropen/hoaf055. eCollection 2025.

    PMID: 40989217DERIVED

  • Olsen AR, Asserhoj LL, Pinborg A, Clausen TD, Greisen G, Jensen RB, Main KM, Vejlstrup NG, Madsen PL, Mizrak I. Visceral and subcutaneous adipose tissue in children born after ART with frozen and fresh embryo transfers. Hum Reprod Open. 2025 Mar 17;2025(2):hoaf014. doi: 10.1093/hropen/hoaf014. eCollection 2025.

    PMID: 40196045DERIVED

  • Asserhoj LL, Mizrak I, Lebech Kjaer AS, Clausen TD, Hoffmann ER, Greisen G, Main KM, Madsen PL, Pinborg A, Jensen RB. Blood pressure and lipid profiles in children born after ART with frozen embryo transfer. Hum Reprod Open. 2024 Mar 20;2024(2):hoae016. doi: 10.1093/hropen/hoae016. eCollection 2024.

    PMID: 38600915DERIVED

  • Asserhoj LL, Mizrak I, Heldarskard GF, Clausen TD, Hoffmann ER, Greisen G, Main KM, Madsen PL, Jensen RB, Pinborg A. Childhood BMI after ART with frozen embryo transfer. Hum Reprod. 2023 Aug 1;38(8):1578-1589. doi: 10.1093/humrep/dead127.

    PMID: 37349895DERIVED

  • Mizrak I, Asserhoj LL, Lund MAV, Kielstrup LR, Greisen G, Clausen TD, Main KM, Jensen RB, Vejlstrup NG, Madsen PL, Pinborg A. Cardiovascular function in 8- to 9-year-old singletons born after ART with frozen and fresh embryo transfer. Hum Reprod. 2022 Mar 1;37(3):600-611. doi: 10.1093/humrep/deab284.

    PMID: 35015837DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A blood test of 10 ml (serum + plasma) will be stored for a biobank at Righsospitalet with the purpose of later analysis of endocrine and metabolic health markers and further for analyses of epigenetic markers.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Anja B. Pinborg, Prof., MD

    Fertility Department, Rigshospitalet

    PRINCIPAL INVESTIGATOR

  • Per L. Madsen, DMSc

    Department of Cardiology S103, HGH

    STUDY CHAIR

  • Rikke B. Jensen, MD, PhD

    Department of Growth and Reproduction, Rigshospitalet

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD, DMSc

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 25, 2018

Study Start

January 5, 2019

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

DK(1)