Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome in Singleton and Multiple Pregnancies: A Multicenter Prospective Cohort Study

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Singleton or multiple pregnancies

• Live fetus between 11 weeks plus 0 days and 13 weeks plus 6 days of gestation

Locations
Other Locations
Bulgaria
University Hospital of Pleven
NOT_YET_RECRUITING
Pleven
Greece
Aristotle University of Thessaloniki
RECRUITING
Thessaloniki
Spain
Hospital Universitario de Torrejón
NOT_YET_RECRUITING
Madrid
Universidad Francisco de Vitoria
NOT_YET_RECRUITING
Madrid
Hospital Clínico Universitario virgen de la Arrixaca
NOT_YET_RECRUITING
Murcia
Complejo Hospitalario Universitario de Canarias
NOT_YET_RECRUITING
Santa Cruz De Tenerife
Contact Information
Primary
Themistoklis Dagklis
dagklis@auth.gr
+302313312120
Backup
Antonios Siargkas
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 12084
Treatments
ART group - Study group
The study group will include pregnant individuals aged 18 years or older with singleton or multiple pregnancies conceived through assisted reproductive technologies. Participants will be recruited during routine first-trimester ultrasound examinations between 11 weeks plus 0 days and 13 weeks plus 6 days of gestation at participating fetal medicine units. Pregnancies with major fetal anomalies or known genetic conditions will be excluded from the primary analysis.
Natural conception group- Control group
The control group will include pregnant individuals aged 18 years or older with singleton or multiple pregnancies conceived spontaneously, without the use of assisted reproductive technologies. Participants will be recruited during routine first-trimester ultrasound examinations between 11 weeks plus 0 days and 13 weeks plus 6 days of gestation at participating fetal medicine units. Pregnancies with major fetal anomalies or known genetic conditions will be excluded from the primary analysis.
Sponsors
Collaborators: University Hospital, Pleven, Bulgaria, Hospital Universitario de Torrejón,Madrid, Hospital Universitario Virgen de la Arrixaca, Universidad Francisco de Vitoria, Hospital Universitario de Canarias
Leads: Aristotle University Of Thessaloniki

This content was sourced from clinicaltrials.gov