Do prenatal effects on baby development occur in IVF pregnancies without shared genes?
Leveraging IVF to Identify Prenatal Effects Independent of Shared Maternal-Child Genes
This research will test whether maternal stress during pregnancy affects a baby's brain and behavior even when the mother and baby do not share genes by comparing donor-egg/embryo IVF pregnancies with non-donor IVF pregnancies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07296107 on ClinicalTrials.gov |
What this trial studies
The project compares pregnancies conceived with donor eggs or embryos (no shared maternal-child genetics) to non-donor IVF pregnancies to separate prenatal environmental effects from shared genes. Pregnant participants complete questionnaires and provide blood samples, while fetal monitoring captures fetal heart rate patterns in the third trimester. After birth, the team collects placenta and cord blood and performs newborn brain activity assessments to link prenatal stress and biological markers to early neurobehavioral outcomes. Epigenetic and transcriptomic analyses of the placenta will test whether maternal distress relates to gene methylation patterns that could mediate infant outcomes.
Who should consider this trial
Good fit: Pregnant individuals aged 18–50 at 18–28 weeks gestation with IVF pregnancies (either donor oocyte/embryo or non-donor) who receive prenatal care and plan to deliver at Columbia University Irving Medical Center/NewYork-Presbyterian Morgan Stanley Children's Hospital are ideal candidates.
Not a fit: People with an active addiction disorder, severe unmanaged psychiatric conditions, or those who do not receive care or deliver at the specified Columbia/NewYork-Presbyterian sites are not expected to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this work could clarify whether prenatal mental health directly influences infant brain development and help target prenatal mental health support to improve child outcomes.
How similar studies have performed: Decades of DOHaD research link prenatal maternal distress to child outcomes, but using donor-conception IVF to separate genetic from prenatal effects in a multidisciplinary epigenetic and neurobehavioral design is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Columbia University Irving Medical Center/New York Presbyterian Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Catherine Monk, PhD — Columbia University
- Study coordinator: Catherine Monk, PhD
- Email: cem31@cumc.columbia.edu
- Phone: 917-543-6031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.