RecruitingNot Applicable

In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics

United States360 participantsStarted 2026-05

Plain-language 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

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Individuals at 22-26 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 will include the offspring of patients receiving care at the above institutions.
✓. 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

✕. Current cigarette smoking
✕. Active drug use
✕. Unstable psychiatric condition
✕. Multiple fetal pregnancy
✕. Known chromosomal, genetic, or major fetal malformations (unlikely due to routine preimplantation genetic testing)

What they're measuring

Change in fetal heart rate (FHR)

Timeframe: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)

Standard deviation of fetal heart rate

Timeframe: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)

Cross correlation of fetal movement and heart rate change

Timeframe: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)

Average percent DNA methylation of the FKBP5 gene in placental tissue

Timeframe: At delivery (approximately 37-40 weeks)

Average percent DNA methylation of the HSD11B2 gene in placental tissue

Timeframe: At delivery (approximately 37-40 weeks)

Relative expression of key pro-inflammatory markers in placental tissue

Timeframe: At delivery (approximately 37-40 weeks)

Trial details

NCT IDNCT07296107

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-07-31

Contact for this trial

Catherine Monk, PhD

917-543-6031 cem31@cumc.columbia.edu

View on ClinicalTrials.gov More Maternal Distress trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Individuals at 22-26 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 will include the offspring of patients receiving care at the above institutions.
✓. 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

✕. Current cigarette smoking
✕. Active drug use
✕. Unstable psychiatric condition
✕. Multiple fetal pregnancy
✕. Known chromosomal, genetic, or major fetal malformations (unlikely due to routine preimplantation genetic testing)

What they're measuring

Change in fetal heart rate (FHR)

Timeframe: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)

Standard deviation of fetal heart rate

Timeframe: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)

Cross correlation of fetal movement and heart rate change

Timeframe: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)

Average percent DNA methylation of the FKBP5 gene in placental tissue

Timeframe: At delivery (approximately 37-40 weeks)

Average percent DNA methylation of the HSD11B2 gene in placental tissue

Timeframe: At delivery (approximately 37-40 weeks)

Relative expression of key pro-inflammatory markers in placental tissue

Timeframe: At delivery (approximately 37-40 weeks)