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

NCT06334003 | Recruiting

• 1 other identifier: H-23071266
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

ART; IVF; Children, Only; Cardiovascular Disease Other

Keywords

Frozen embryo transfer; Cardiovascular; Metabolic; IVF

Outcome Measures

Primary Outcomes (2)

• Offspring body composition

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

  Assessed at 2,5 months of age

• Maternal cardiometabolic profile

  Fetal growth patterns determined by ultrasound

  One times during each trimester

Secondary Outcomes (3)

• Epigenetic in placenta and cord blood

  2 years

• Early markers of reproductive function in FET, fresh-ET and NC children: LH, FSH, SHBG, AMH, androgens, estrogens (SDS)

  3 years

• Telomere length in children born after FET, fresh-ET and NC children

  3 years

Study Arms (3)

FET-group

Children conceived by frozen embryo transfer

Fresh ET-group

Children conceived by fresh embryo transfer

NC group

Naturally conceived children

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• Maternal pregestational diabetes type 1 or 2
• Non-singleton pregnancies
• Maternal pregestational BMI \> 35 kg/m2
• Severe maternal co-morbidity
• Oocyte donation

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Herlev Hospital: collaborator

Study Sites (3)

Fertility Clinic, Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

Department of Fetalmedicin, Herlev Hospital

Copenhagen, Denmark

RECRUITING

Dept. of Paediatric and Adolescent Medicine, Herlev Hospital

Copenhagen, Denmark

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 40957860 DERIVED

Study Officials

• Anja B. Pinborg, Prof., MD

  Fertility Department, Rigshospitalet

  PRINCIPAL INVESTIGATOR

• Rikke B. Jensen, MD, Ass. prof

  Dept. of Paediatric and Adolescent Medicine, Herlev Hospital

  STUDY CHAIR

Central Study Contacts

Maria L Vestager, MD

CONTACT

+4528306039; maria.linander.vestager.01@regionh.dk

Anna Sophie Lebech Kjær, MD

CONTACT

anna.sophie.lebech.kjaer.02@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 27, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

DK (3)