HiCART
Cardiovascular and Metabolic Profiles in Pre-pubertal Singletons Aged 6-8 Years of Age Conceived After Frozen Embryo Transfer Compared to Singletons Conceived After Fresh Embryo Transfer and After Natural Conception
Sponsor study identifier
observational
606
1 country
1
Study Start
January 5, 2019
Actual (reported)Primary Completion
September 1, 2021
Actual (reported)Study Completion
September 1, 2021
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 23, 2018
Actual (reported)October 25, 2018
Actual (reported)January 5, 2019
Actual (reported)September 1, 2021
Actual (reported)September 1, 2021
Actual (reported)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
HOMA-IR
At admission
Children conceived by frozen embryo transfer
Children conceived by fresh embryo transfer
Naturally conceived children
The study population will be recruited from the Capital Region of Denmark.
Fertilitetsklinikken 4071
Copenhagen, Denmark
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.
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.
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.
Anja B. Pinborg, Prof., MD
Fertility Department, Rigshospitalet
Per L. Madsen, DMSc
Department of Cardiology S103, HGH
Rikke B. Jensen, MD, PhD
Department of Growth and Reproduction, Rigshospitalet
606 participants (actual enrollment reported by the registry).
First Submitted
October 23, 2018
First Posted
October 25, 2018
Study Start
January 5, 2019
Actual (reported)Central Arterial Hemodynamics and Resistance Training
DXA scan
At admission
Epigenetics
After admission
Blood pressure
at admission
Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
September 1, 2021
Actual (reported)Study Completion
September 1, 2021
Actual (reported)Last Updated
March 30, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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