Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome

NCT06918236 | Recruiting

• 1 other identifier: 320/2024
• Study Type: observational
• Target: 12,084
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

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

Keywords

fetal growth restriction; Preeclampsia; stillbirth; placenta previa; vasa previa; Assisted reproductive techniques; ART; Small for Gestational Age (SGA); IVF; ICSI

Outcome Measures

Primary Outcomes (4)

• Small for gestational age neonates

  Small for gestational age neonates defined as birthweight lower than the 10th percentile

  At delivery/birth

• Development of preeclampsia

  New onset of hypertension (systolic pressure ≥140 and/or diastolic pressure ≥90 mmHg) and proteinuria or the new onset of hypertension plus significant end-organ dysfunction with or without proteinuria, typically presenting after 20 weeks of gestation or postpartum.

  From the 20th gestational week and up to 8 weeks after the delivery/birth

• Fetal growth restriction

  Fetal growth restriction, either early-onset (\<32 weeks) or late-onset (\>32 weeks), characterized by an estimated fetal weight below the 3rd percentile or below the 10th percentile based on the Fetal Medicine Foundation fetal growth charts accompanied by abnormal Doppler findings; or birthweight below the 5th centile based on the FMF neonatal growth charts

  From the 22nd gestational week and up to the delivery/birth

• Stillbirth

  Stillbirth (intrauterine demise after 22 weeks gestation not attributable to other causes (i.e. congenital infections, structural defects, genetic anomalies)

  From the 24th gestational week and up to the delivery/birth

Secondary Outcomes (4)

• Placenta previa

  From the 20th gestational week up to the 24th gestational week.

• Vasa previa

  From the 20th gestational week up to the 24th gestational week.

• Single umbilical artery

  From the 20th gestational week up to the 24th gestational week.

• Velamentous and marginal cord insertions

  From the 20th gestational week up to the 24th gestational week.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive women 18 years old or older who attend for routine ultrasound examination at 11 weeks plus 0 days to 13 weeks plus 6 days of gestation at one of participating fetal medicine units.

You may qualify if:

• Singleton or multiple pregnancies
• Live fetus between 11 weeks plus 0 days and 13 weeks plus 6 days of gestation

You may not qualify if:

• Known genetic anomalies diagnosed before or after birth
• Major fetal defects diagnosed before or after birth, such as acrania, holoprosencephaly, megacystis, exomphalos, congenital heart defects

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Hospital Universitario de Torrejón,Madrid: collaborator
• Universidad Francisco de Vitoria: collaborator
• University Hospital, Pleven, Bulgaria: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator
• Hospital Universitario de Canarias: collaborator

Study Sites (6)

University Hospital of Pleven

Pleven, 5800, Bulgaria

NOT YET RECRUITING

Aristotle University of Thessaloniki

Thessaloniki, Central Macedonia, 54124, Greece

RECRUITING

Complejo Hospitalario Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, 38320, Spain

NOT YET RECRUITING

Universidad Francisco de Vitoria

Madrid, 28223, Spain

NOT YET RECRUITING

Hospital Universitario de Torrejón

Madrid, 28850, Spain

NOT YET RECRUITING

Hospital Clínico Universitario "virgen de la Arrixaca"

Murcia, 30120, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation; Pre-Eclampsia; Stillbirth; Placenta Previa; Vasa Previa

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Fetal Death; Death; Obstetric Labor Complications; Placenta Diseases

Central Study Contacts

Themistoklis Dagklis

CONTACT

+302313312120; dagklis@auth.gr

Antonios Siargkas

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 9, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

BU (1); GR (1); ES (4)