RecruitingNCT07296107

In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics

Leveraging IVF to Identify Prenatal Effects Independent of Shared Maternal-Child Genes

Sponsor

Columbia University

Enrollment

360 participants

Start Date

May 1, 2026

Study Type

OBSERVATIONAL

Conditions

Child Development Maternal Distress

Summary

This study examines how maternal stress during pregnancy affects infant brain and behavioral development, focusing on whether these effects are due to the prenatal environment or shared genes. By comparing IVF pregnancies using donor eggs/embryos (no shared genetics) with non-donor IVF pregnancies, the investigators aim to understand how stress influences the baby's development independent of genetic factors. Participants will complete questionnaires, provide blood samples, and take part in placenta and cord blood collection, fetal monitoring, and newborn brain activity assessments. Aim 1: The influence of maternal distress on perinatal neurobehavioral development. Hypotheses: Independent of IVF group status, higher maternal AL will be associated with higher 3rd trimester FHR reactivity, lower FHR variability, AND lower FHR-movement coupling Aim 2: Maternal distress affecting placenta gene methylation. Hypotheses: Independent of IVF group status, maternal AL will be associated with placenta differential DNA methylation in glucocorticoid-regulating genes (FKBP5 and HSD11B2), Aim 3: Maternal experiences associated with unique placenta transcriptomic profiles. Hypotheses: Independent of IVF group status, maternal AL and well-being each will be associated with unique placenta gene expression in pro-inflammatory genes

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

Individuals at 22-26 gestational weeks with donor and homologous IVF pregnancies, ages 18-50.
Participants must be patients receiving their perinatal health care through Columbia University Irving Medical Center's Department of OB/GYN and delivering at New York-Presbyterian Morgan Stanley Children's Hospital.
Participants will include the offspring of patients receiving care at the above institutions.
Enrollment Location(s): Columbia University Irving Medical Center's Department of OB/GYN, delivering at New York-Presbyterian Morgan Stanley Children's Hospital.

Exclusion Criteria8

Current cigarette smoking
Active drug use
Unstable psychiatric condition
Multiple fetal pregnancy
Known chromosomal, genetic, or major fetal malformations (unlikely due to routine preimplantation genetic testing)
Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis
Current use of synthetic glucocorticoids
Not planning to deliver at a CUIMC-affiliated hospital

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Interventions

OTHERPrenatal maternal psychosocial and biological assessment protocol

This is not a therapeutic or experimental intervention. The data-collection protocol includes structured psychosocial questionnaires, physiological monitoring, maternal blood draws, placental and cord blood collection, and newborn physiological monitoring. These procedures are used to observe associations between maternal prenatal distress and infant outcomes. All participants undergo the same assessments; no clinical treatment or behavioral manipulation is delivered.