NCT06918236Recruiting
Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome
Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome in Singleton and Multiple Pregnancies: A Multicenter Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 12084 (estimated)
- First submitted
- 29 Mar 2025
- Start date
- 1 Oct 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Aristotle University Of Thessaloniki
- NCT number
- NCT06918236
What you commit to
- Study type: Observational
- Planned participants: 12084
- From 1 Oct 2024 to the primary completion date, Dec 2027
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Major fetal defects diagnosed before or after birth, such as acrania, holoprosencephaly, megacystis, exomphalos, congenital heart defects
Other
- Known genetic anomalies diagnosed before or after birth
Who the study is looking for
- Singleton or multiple pregnancies
- Live fetus between 11 weeks plus 0 days and 13 weeks plus 6 days of gestation
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Pleven Coordinator of this site? Confirm its status | Pleven | Bulgaria | Not yet recruiting |
| Hospital Universitario de Torrejón Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Universidad Francisco de Vitoria Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Complejo hospitalario Universitario de Canarias Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Not yet recruiting |
| Aristotle University of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.