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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

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital of Pleven
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PlevenBulgariaNot yet recruiting
Hospital Universitario de Torrejón
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Universidad Francisco de Vitoria
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Coordinator of this site? Confirm its status
MurciaSpainNot yet recruiting
Complejo hospitalario Universitario de Canarias
Coordinator of this site? Confirm its status
Santa Cruz de TenerifeSpainNot yet recruiting
Aristotle University of Thessaloniki
Coordinator of this site? Confirm its status
ThessalonikiGreeceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.