Prenatal stress and newborn health in assisted reproduction pregnancies
Official title: The Effects of Antenatal Stress on the Newborn in Medically Assisted Reproduction: the SARA Study
Run by IRCCS Eugenio Medea · NCT07408453 · Data updated 2026-11-12
Researchers will see if psychological and biological signs of stress in parents who conceived using medically assisted reproduction are linked to newborn health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bergamo, Bergamo) |
| Status | Recruiting |
| Started | April 2026 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07408453 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are pregnant women in their first trimester and their partners who conceived a singleton pregnancy via FIVET (homologous fertilization or oocyte donation), without major medical, endocrine, immune, substance use, smoking, or excluded psychiatric disorders.
✕Probably not a fit
People who conceived without FIVET, with donor sperm, multiple pregnancies, preterm birth before 35 weeks, major pregnancy complications, chronic medication use, active substance use, or excluded psychiatric/medical conditions are unlikely to qualify or benefit from the study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a longitudinal observational study enrolling pregnant women and their partners who conceived through FIVET, including both homologous fertilization and oocyte donation, with data collected during pregnancy and at birth. Mothers and fathers complete online questionnaires about anxiety, depression, social support, and related measures, while mothers provide pregnancy-specific measures; biological stress markers such as salivary cortisol and alpha-amylase are also collected. A cross-fostering design comparing genetically related and unrelated mother–infant pairs (oocyte donation) is used to help separate prenatal environmental effects from genetic influences. Participants are recruited through fertility centers, screened for major psychiatric or medical exclusions, and followed across multiple timepoints until delivery.
Why it matters
Potential benefit: If successful, the findings could clarify how prenatal stress affects infant health in assisted reproduction and help target prenatal support for these families.
How similar studies have gone: Related research has linked prenatal stress to infant outcomes and the investigators reference prior EDI work, but using a cross-fostering design to separate prenatal versus genetic effects is relatively uncommon.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women in the first trimester and their respective partners. * Pregnancy achieved through homologous assisted reproduction techniques. * Pregnancy achieved through heterologous assisted reproduction via oocyte donation. * Singleton pregnancy. * Pregnancy achieved through FIVET techniques. Exclusion Criteria: * Parents under 18 years of age. * Pregnancy achieved through heterologous assisted reproduction via donor sperm. * Pregnancy achieved without FIVET techniques. * Maternal hypertension during pregnancy. * Endocrine or immune system disorders during pregnancy. * Chronic use of medications during pregnancy (including anti-inflammatory drugs, antidepressants, or steroids). * Alcohol or substance abuse. * Smoking during pregnancy. * Psychiatric disorders other than anxiety or depression. * Pregnancy or perinatal complications. * Multiple pregnancy (twins or higher-order multiples). * Preterm birth (before 35 weeks of gestation). * Health problems in the newborn at birth.
Where it's running
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Ospedale Papa Giovanni XXIII
Bergamo, Bergamo, Italy Recruiting
Study contacts
- Study coordinator: Alessandra Frigerio, PhD
- Email: alessandra.frigerio@lanostrafamiglia.it
- Phone: +39031877595
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.