Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAristotle University Of Thessaloniki

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Singleton or multiple pregnancies

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

12,084 Participants
are grouped into 2 trial groups
Group A: ART group - Study group
Group B: Natural conception group- Control group

Trial outcomes

Primary outcomes

1

Small for gestational age neonates

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

Time frame
At delivery/birth
2

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.

Time frame
From the 20th gestational week and up to 8 weeks after the delivery/birth
3

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

Time frame
From the 22nd gestational week and up to the delivery/birth
4

Stillbirth

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

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

Secondary outcomes

1

Placenta previa

Placenta partially or completely covers the internal cervical os.

Time frame
From the 20th gestational week up to the 24th gestational week.
2

Vasa previa

Vasa previa occurs when fetal blood vessels that are unprotected by the umbilical cord or placenta run through the amniotic membranes and traverse the cervix.

Time frame
From the 20th gestational week up to the 24th gestational week.
3

Single umbilical artery

Umbilical cord with one instead of two umbilical arteries

Time frame
From the 20th gestational week up to the 24th gestational week.
4

Velamentous and marginal cord insertions

Abnormal cord insertions

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aristotle University Of Thessaloniki

Lead sponsor

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