Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology
NCT ID: NCT06334003
Last Updated: 2024-11-25
Study Results
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Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-05-17
2027-01-01
Brief Summary
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Detailed Description
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Hypothesis and objectives: The growth hormone (GH) - insulin-like growth factor (IGF) axis plays an essential role in fetal growth and is also linked to metabolic disease due to its interactions with insulin. Thus, the investigator group hypothesize that FET imposes epigenetic alterations towards the GH-IGF-axis leading to enhanced fetal growth and a potential persisting phenotype of metabolic dysfunction. The objective is to determine the effect of endocrine growth factors, maternal metabolic profile, and placental function on intrauterine growth patterns as well as early postnatal body composition and metabolic profile in children born after ART with FET compared to children born after fresh ET and NC children.
Methods and outcomes: The investigator group will conduct a prospective cohort study including women pregnant by FET (N=200), fresh ET (N=200) and NC children (N=200). The women will undergo three examinations during pregnancy with blood sampling (analyzed for GH-IGF-related growth factors and metabolic biomarkers), fetal biometry and doppler ultrasound. For a subpopulation the placenta will be collected at delivery. The expression of placental growth factors will be determined using western blot and qPCR and epigenetic alterations assessed by DNA methylation using targeted CpG arrays. The newborns will be examined within two weeks of birth with blood samples (analyzed for growth factors, glucose-metabolism markers, lipids, and cytokines) and a DEXA-scan to evaluate body composition. Information on ART-procedure, obstetric adverse events, birth weight and neonatal complications will be available from electronic health records. The outcomes are grouped in three work packages comparing the differences between FET, fresh ET, and NC in 1) maternal growth factors and metabolic profile and the relationship with fetal growth trajectories, 2) expression and DNA methylation of GH-IGF-axis components in placental tissue, 3) body composition, metabolic profile and DNA methylation of regions related to the GH-IGF axis in neonates.
Significance: It is crucial to understand the mechanism between FET and LGA and its impact on metabolic health in children in order to determine the safest ART technique. The investigator group expect that the results will identify the role of the GH-IGF axis in the pathogenesis of FET-induced LGA and its associated metabolic risk which may highlight potential biomarkers of abnormal fetal growth and therapeutic targets for prevention of obesity and metabolic diseases.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FET-group
Children conceived by frozen embryo transfer
No interventions assigned to this group
Fresh ET-group
Children conceived by fresh embryo transfer
No interventions assigned to this group
NC group
Naturally conceived children
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non-singleton pregnancies
* Maternal pregestational BMI \> 35 kg/m2
* Severe maternal co-morbidity
* Oocyte donation
18 Years
40 Years
ALL
Yes
Sponsors
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Herlev Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Anja Bisgaard Pinborg
Clinical Professor
Principal Investigators
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Anja B. Pinborg, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Fertility Department, Rigshospitalet
Rikke B. Jensen, MD, Ass. prof
Role: STUDY_CHAIR
Dept. of Paediatric and Adolescent Medicine, Herlev Hospital
Locations
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Fertility Clinic, Rigshospitalet, Copenhagen University Hospital
Copenhagen, , Denmark
Department of Fetalmedicin, Herlev Hospital
Copenhagen, , Denmark
Dept. of Paediatric and Adolescent Medicine, Herlev Hospital
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Anja B. Pinborg, Prof., MD
Role: primary
Rikke B. Jensen, MD, Ass. Prof
Role: primary
References
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Kjaer ASL, Vestager ML, Blixenkrone-Moller E, Asserhoj LL, Kloppenborg JT, Lossl K, Ekelund CK, Rode L, Hjort L, Hoffmann ER, Lyng Forman J, Beck Jensen R, Pinborg A. Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART): a prospective cohort study. BMJ Open. 2025 Sep 16;15(9):e105754. doi: 10.1136/bmjopen-2025-105754.
Other Identifiers
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H-23071266
Identifier Type: -
Identifier Source: org_study_id
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