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Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology

ConditionsARTIVFChildren, OnlyCardiovascular Disease Other
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Maternal pregestational diabetes type 1 or 2

Non-singleton pregnancies

Maternal pregestational BMI > 35 kg/m2

Severe maternal co-morbidity

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 3 trial groups
Group A: FET-group
Group B: Fresh ET-group
Group C: NC group

Trial outcomes

Primary outcomes

1

Offspring body composition

Total fat mass (in gram) assessed by air displacement plethysmography (PEA POD).

Time frame
Assessed at 2,5 months of age
2

Maternal cardiometabolic profile

Fetal growth patterns determined by ultrasound

Time frame
One times during each trimester

Secondary outcomes

1

Epigenetic in placenta and cord blood

Differences between ovulatory FET, programmed FET, fresh ET and NC

Time frame
2 years
2

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

Time frame
3 years
3

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

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Herlev Hospital

Collaborator

Source ClinicalTrials.gov
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