Investigating cardiometabolic health in mothers and children after assisted reproductive technology
Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology
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 |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 3 sites (Copenhagen and 2 other locations) |
| Trial ID | NCT06334003 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant women who have undergone fertility treatment or are scheduled for prenatal ultrasounds at the participating hospitals.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Copenhagen and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.