In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorColumbia University
About this trial
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
Qualifiers
Individuals at 18-28 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 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.
Participants will include the offspring of patients receiving care and delivering at the above institutions.
Disqualifiers
Identified addiction disorder
Severe psychiatric condition (defined as symptoms that significantly impair daily functioning and are untreated or not effectively managed)
Multiple fetal pregnancy
Known chromosomal, genetic, or major fetal malformations (unlikely due to routine preimplantation genetic testing)
Trial design
Treatments tested in this trial
- Prenatal maternal psychosocial and biological assessment protocol
Treatment groups
360 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
University of California, Los Angeles
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov