Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-26
Brief Title:
Cardiometabolic Function in Offspring Mother and Placenta After Assisted Reproductive Technology
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Cardiometabolic Function in Offspring Mother and Placenta After Assisted Reproductive Technology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPART
Brief Summary:
The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women biological fatherspartners and offspring from pregnancies achieved by frozen embryo transfer FET fresh-embryo transfer fresh ET and naturally conceived NC to investigate maternal cardiometabolic profiles fetal growth patterns and placental function during pregnancy as well as metabolic and endocrine health in the offspring Additionally the aim is to explore genetic and epigenetic patterns in placenta fetus and parents As secondary objectives the investigator group will examine telomere length and minipuberty hormones in children born after FET fresh-ET and NC
Detailed Description:
Background and research gap Increasing use of assisted reproductive technology ART necessitates vigilance on the health of the offspring The use of frozen embryo transfer FET in ART increases the risk of the children being born large-for-gestational-age LGA compared to conventional fresh embryo transfer fresh ET and naturally conceived children NC In general children born LGA are predisposed to childhood obesity and later metabolic syndrome thus FET may increase the societal burden of this The mechanism between FET and LGA is unclear and its impact on neonatal body composition and metabolic health is unknown
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 N200 fresh ET N200 and NC children N200 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
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 N200 fresh ET N200 and NC children N200 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None