Investigating cardiometabolic health in mothers and children after assisted reproductive technology
Official title: Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology
Run by Copenhagen University Hospital, Rigshospitalet · NCT06334003 · Data updated 2026-11-12
This study is trying to understand the health of mothers and their children conceived through different methods, like frozen or fresh embryo transfers, to see how these methods affect their heart and metabolic health during and after pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 3 sites (Copenhagen and 2 other locations) |
| Status | Recruiting |
| Started | May 17, 2024 |
| Main results expected | May 30, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | November 25, 2024 |
| Trial ID | NCT06334003 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women who have undergone fertility treatment or are scheduled for prenatal ultrasounds at the participating hospitals.
✕Probably not a fit
Patients with pregestational diabetes, non-singleton pregnancies, high maternal BMI, severe co-morbidities, or those using oocyte donation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to create a longitudinal cohort of pregnant women, their partners, and offspring conceived through frozen embryo transfer (FET), fresh embryo transfer (fresh ET), and natural conception (NC). It will assess maternal cardiometabolic profiles, fetal growth patterns, and placental function during pregnancy, as well as the metabolic and endocrine health of the offspring. The study will also explore genetic and epigenetic patterns in the placenta, fetus, and parents, while examining telomere length and hormone levels in children born from these different conception methods.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term health implications for children conceived through assisted reproductive technologies.
How similar studies have gone: While this study addresses a novel research gap, similar studies have indicated potential health risks associated with assisted reproductive technologies, suggesting a need for further investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fertility Clinic, Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark Recruiting -
Department of Fetalmedicin, Herlev Hospital
Copenhagen, Denmark Recruiting -
Dept. of Paediatric and Adolescent Medicine, Herlev Hospital
Copenhagen, Denmark Not yet recruiting
Study contacts
- Principal investigator: Anja B. Pinborg, Prof., MD — Fertility Department, Rigshospitalet
- Study coordinator: Maria L Vestager, MD
- Email: maria.linander.vestager.01@regionh.dk
- Phone: +4528306039
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.