RecruitingNCT06918236

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


Sponsor

Aristotle University Of Thessaloniki

Enrollment

12,084 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is looking at the connection between fertility treatment (assisted reproductive technologies, or ART) parameters and pregnancy or birth outcomes. Researchers are analyzing data from pregnancies in their early stage to understand how ART affects the baby's health. **You may be eligible if...** - You have a singleton (one baby) or multiple pregnancy - Your pregnancy is between 11 weeks and 1 day, and 13 weeks and 6 days along - Your baby has a confirmed heartbeat (live fetus) **You may NOT be eligible if...** - Your baby has been diagnosed with a known genetic abnormality before or after birth - Your baby has a major structural defect (such as a brain malformation, large abdominal wall defect, or heart defect) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(6)

University Hospital of Pleven

Pleven, Bulgaria

Aristotle University of Thessaloniki

Thessaloniki, Central Macedonia, Greece

Complejo Hospitalario Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Universidad Francisco de Vitoria

Madrid, Spain

Hospital Universitario de Torrejón

Madrid, Spain

Hospital Clínico Universitario "virgen de la Arrixaca"

Murcia, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06918236


Related Trials