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NCT07296107
In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics
Conditions: Maternal Distress, Child Development
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Enrollment: 360
Sponsor: Columbia University
Location: Columbia University Irving Medical Center/New York Presbyterian Hospital New York New York
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 Criteria
Inclusion Criteria:
1. Individuals at 18-28 gestational weeks with donor and homologous IVF pregnancies, ages 18-50.
2. 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.
3. Participants must be patients delivering at Columbia University Irving Medical Center's Department of OB/GYN and delivering at New York-Presbyterian Morgan Stanley Children's Hospital.
4. Participants will include the offspring of patients receiving care and delivering at the above institutions.
5. Enrollment Location(s): Columbia University Irving Medical Center's Department of OB/GYN, delivering at New York-Presbyterian Morgan Stanley Children's Hospital.
Exclusion Criteria:
1. Identified addiction disorder
2. Severe psychiatric condition (defined as symptoms that significantly impair daily functioning and are untreated or not effectively managed)
3. Multiple fetal pregnancy
4. Known chromosomal, genetic, or major fetal malformations (unlikely due to routine preimplantation genetic testing)
5. Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis
6. Not planning to deliver at a CUIMC-affiliated hospital
Source: ClinicalTrials.gov (NCT07296107). StuddyBuddy aggregates publicly available trial information.