NCT06334003 Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology
| NCT ID | NCT06334003 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | ART |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-05-17 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-05-17 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Anja B. Pinborg, Prof., MD
PRINCIPAL INVESTIGATOR
Fertility Department, Rigshospitalet
Frequently Asked Questions
Who can join the NCT06334003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying ART. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06334003 currently recruiting?
Yes, NCT06334003 is actively recruiting participants. Contact the research team at maria.linander.vestager.01@regionh.dk for enrollment information.
Where is the NCT06334003 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Copenhagen, Denmark, Copenhagen, Denmark.
Who is sponsoring the NCT06334003 clinical trial?
NCT06334003 is sponsored by Rigshospitalet, Denmark. The principal investigator is Anja B. Pinborg, Prof., MD at Fertility Department, Rigshospitalet. The trial plans to enroll 600 participants.