NCT07296107 In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics
| NCT ID | NCT07296107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Maternal Distress |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2026-05 |
| Primary Completion | 2030-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2026-05 with a primary completion date of 2030-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Catherine Monk, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT07296107 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Maternal Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07296107 currently recruiting?
Yes, NCT07296107 is actively recruiting participants. Contact the research team at cem31@cumc.columbia.edu for enrollment information.
Where is the NCT07296107 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07296107 clinical trial?
NCT07296107 is sponsored by Columbia University. The principal investigator is Catherine Monk, PhD at Columbia University. The trial plans to enroll 360 participants.