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
This trial accepts healthy volunteersQualifiers
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 population
This five-year study will recruit and enroll approximately 200 pregnant individuals, ages 18-50 years, using IVF (120 homologous, 60 donor oocyte/embryo) and their offspring to achieve a post-attrition sample size of n=180. While based in Washington Heights, the sample reflects individuals undergoing IVF, not the general neighborhood. Based on Columbia Fertility Center data and national IVF trends, the investigators expect participants to be mostly Non-Hispanic/Latinx. While the investigators aim for inclusivity and diversity, non-English speakers will not be enrolled due to study team language constraints.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Prenatal maternal psychosocial and biological assessment protocol
Other interventionThis 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Donor Oocyte/Embryo IVF Pregnancies1 intervention
Group B: Non-Donor Oocyte IVF Pregnancies1 intervention
Trial outcomes
Primary outcomes
1
Change in fetal heart rate (FHR)
This is to measure 3rd trimester fetal heart rate (FHR) reactivity. Change in FHR in response to maternal response to the Stroop task, indicating greater fetal autonomic response associated with maternal distress. Units: Beats per minute (bpm). Greater FHR indicates higher stress.
Time frame
At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)2
Standard deviation of fetal heart rate
This is to measure fetal heart rate (FHR) variability, reflecting less vagal modulation of the heart associated with maternal distress. Units: Standard deviation of beats per minute. Lesser standard deviation (SD) indicates lower stress.
Time frame
At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)3
Cross correlation of fetal movement and heart rate change
This is to measure fetal heart rate (FHR)-movement coupling, reflecting central nervous system regulation. Units: Cross correlation value. Lower value indicates lower coupling.
Time frame
At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)4
Average percent DNA methylation of the FKBP5 gene in placental tissue
This is to measure FKBP5 DNA Methylation. Units: proportion of methylated vs unmethylated. Greater percent indicates higher methylation.
Time frame
At delivery (approximately 37-40 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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