IVF Clinical Trial
— COMPARTOfficial title:
Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology
The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women, biological fathers/partners 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.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | December 1, 2027 |
Est. primary completion date | April 30, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: Pregnant women who have either had fertility treatment at Rigshospitalet or Herlev Hospital (FET and fresh ET groups) or are scheduled for prenatal ultrasounds at Rigshospitalet or Herlev Hospital (NC group) will be screened for eligibility. Inclusion must happen before their routine ultrasound scan in 1. trimester. Exclusion Criteria: - Maternal pregestational diabetes type 1 or 2 - Non-singleton pregnancies - Maternal pregestational BMI > 35 kg/m2 - Severe maternal co-morbidity - Oocyte donation |
Country | Name | City | State |
---|---|---|---|
Denmark | Dept. of Paediatric and Adolescent Medicine, Herlev Hospital | Copenhagen | |
Denmark | Fertility Clinic, Rigshospitalet, Copenhagen University Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Offspring body composition | Total fat mass (in gram) assessed by air displacement plethysmography (PEA POD). | Assessed at 2,5 months of age | |
Primary | Maternal cardiometabolic profile | Fetal growth patterns determined by ultrasound | One times during each trimester | |
Secondary | Epigenetic in placenta and cord blood | Differences between ovulatory FET, programmed FET, fresh ET and NC | 2 years | |
Secondary | Early markers of reproductive function in FET, fresh-ET and NC children: LH, FSH, SHBG, AMH, androgens, estrogens (SDS) | Bloodsamples: Differences between ovulatory FET, programmed FET, fresh ET and NC | 3 years | |
Secondary | Telomere length in children born after FET, fresh-ET and NC children | Differences between ovulatory FET, programmed FET, fresh ET and NC in 1) LTL in newborns and 2) parental LTL | 3 years |
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