Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome

Sponsor
Aristotle University Of Thessaloniki
Study ID
NCT06918236
Status
Recruiting
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Conditions

  • Fetal Growth Restriction (FGR)
  • Placenta Previa
  • Preeclampsia
  • Small for Gestational Age (SGA)
  • Stillbirth
  • Vasa Previa

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Apr 9, 2025
Start date
Oct 1, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
12,084 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Small for gestational age neonates [ Time Frame: At delivery/birth ]

Central Contacts

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