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NCT07296107 · ClinicalTrials.gov registry record
In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics
A clinical trial of Child Development and Maternal Distress, sponsored by Columbia University.
- Recruiting
- Registry status
- 360
- Enrollment target
- 1
- Study location
NCT07296107: Recruiting study of Child Development and Maternal Distress, sponsored by Columbia University.
NCT07296107 is a study of Child Development and Maternal Distress that is actively recruiting participants, run by Columbia University. The registered enrollment target is 360 participants, below the 1,082-participant average among 32 other Child Development trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07296107, a study of Child Development and Maternal Distress, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- 360 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Prenatal maternal psychosocial and biological assessment protocol
Study Locations (1)
New York
- Columbia University Irving Medical Center/New York Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2026-05 |
| Est. Completion | 2030-07-31 |
What NCT07296107 shows while recruiting
NCT07296107 is an observational study that tracks outcomes without assigning an intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 1,082-participant average among 32 other Child Development trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Child Development appearing as the primary indexed condition, and to 1 intervention - of which Prenatal maternal psychosocial and biological assessment protocol is the first listed.
NCT07296107 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07296107 about?
NCT07296107 is a clinical study titled "In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics". 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, ...
What is the current status of trial NCT07296107?
This trial is currently recruiting. The enrollment target is 360 participants. The study started on 2026-05. Estimated completion is 2030-07-31.
What conditions does trial NCT07296107 study?
This clinical trial studies the following conditions: Child Development, Maternal Distress.
What interventions are being tested in trial NCT07296107?
The interventions under investigation include: Prenatal maternal psychosocial and biological assessment protocol (OTHER).
Who is sponsoring clinical trial NCT07296107?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07296107 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07296107's enrollment target sits among peer trials
360 12th of 32 higher than 21 of 32 other Child Development trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Child Development trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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