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

NCT07296107 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2026-05-13

No results posted yet for this study

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

Conditions

  • Maternal Distress
  • Child Development

Interventions

OTHER

Prenatal 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.

Sponsors & Collaborators

Principal Investigators

  • Catherine Monk, PhD · Columbia University

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-07-31
Completion
2030-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07296107 on ClinicalTrials.gov