NCT06918236 Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome
| NCT ID | NCT06918236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aristotle University Of Thessaloniki |
| Condition | Fetal Growth Restriction (FGR) |
| Study Type | OBSERVATIONAL |
| Enrollment | 12,084 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 12,084 participants in total. It began in 2024-10-01 with a primary completion date of 2027-12.
⚠ 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 goal of this prospective cohort study is to examine how different parameters of assisted reproductive technologies (ART) are associated with the perinatal outcome in individuals with singleton or multiple gestations. The main questions it aims to answer are: Are ART pregnancies associated with a higher risk of: * Small for gestational age neonates? * Fetal growth restriction, either early- or late-onset? * Development of preeclampsia? * Stillbirth (intrauterine fetal death after 22 weeks not due to known anomalies)? * Are certain ART parameters-such as the type of fertilization (e.g., IVF vs. ICSI), embryo stage at transfer, use of fresh vs. frozen embryos, or ovarian stimulation protocols-more strongly associated with adverse outcomes? Are ART pregnancies associated with placental and umbilical cord abnormalities, including: * Placenta previa? * Vasa previa? * Single umbilical artery? * Velamentous or marginal cord insertion? Researchers will compare outcomes between pregnancies conceived through ART and those conceived spontaneously. Participants will: * Be individuals aged 18 or older undergoing routine first-trimester ultrasound between 11 and 14 weeks of gestation * Provide detailed medical, obstetric, and ART-related information * Undergo routine prenatal assessments, including ultrasound evaluations of fetal growth, Doppler studies, and placental characteristics * Have perinatal outcomes such as gestational age at birth, mode of delivery, birthweight, and complications systematically recorded Statistical models will be used to adjust for confounding factors such as maternal age, BMI, parity, and smoking. The aim is to better understand how ART and specific ART parameters may influence maternal and neonatal health and to improve counseling and clinical care for people using fertility treatments.
Eligibility Criteria
Inclusion Criteria * Singleton or multiple pregnancies * Live fetus between 11 weeks plus 0 days and 13 weeks plus 6 days of gestation Exclusion Criteria * Known genetic anomalies diagnosed before or after birth * Major fetal defects diagnosed before or after birth, such as acrania, holoprosencephaly, megacystis, exomphalos, congenital heart defects
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06918236 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fetal Growth Restriction (FGR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06918236 currently recruiting?
Yes, NCT06918236 is actively recruiting participants. Contact the research team at dagklis@auth.gr for enrollment information.
Where is the NCT06918236 trial being conducted?
This trial is being conducted at Pleven, Bulgaria, Thessaloniki, Greece, Santa Cruz de Tenerife, Spain, Madrid, Spain and 2 additional locations.
Who is sponsoring the NCT06918236 clinical trial?
NCT06918236 is sponsored by Aristotle University Of Thessaloniki. The trial plans to enroll 12,084 participants.