Do prenatal effects on baby development occur in IVF pregnancies without shared genes?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.