RecruitingNCT07408453

Antenatal Stress and Infants In MAR

The Effects of Antenatal Stress on the Newborn in Medically Assisted Reproduction: the SARA Study


Sponsor

IRCCS Eugenio Medea

Enrollment

100 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational longitudinal study is to examine the association between prenatal psychological and biological stress and neonatal health outcomes in couples who conceived through medically assisted reproduction. The study includes expectant mothers and fathers during pregnancy and at birth and focuses on pregnancies achieved through homologous fertilization and heterologous fertilization via oocyte donation. The main questions this study aims to answer are: 1. How do psychological and biological indicators of stress manifest during pregnancy in women who have undergone medically assisted reproduction? 2. Is prenatal maternal stress associated with neonatal health outcomes independently of genetic factors? 3. How does perceived stress present in expectant fathers during pregnancy? Researchers will compare couples who conceived through homologous fertilization with couples who conceived through heterologous fertilization via oocyte donation to understand whether associations between prenatal maternal stress and neonatal outcomes are independent of shared genetic background. Participants will: * Complete a remote eligibility assessment collecting information on pregnancy characteristics, parental health, and maternal psychological well-being * Complete online questionnaires at multiple time points during pregnancy and at birth assessing anxiety and depressive symptoms, perceived social support, and self-efficacy (both parents), as well as pregnancy-specific measures and prenatal bonding (mothers only) * In late pregnancy, mothers will collect saliva samples at home over two consecutive days to assess biological markers of stress (cortisol and alpha-amylase)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines the relationship between stress during pregnancy (from fertility treatments) and the health and development of infants. It involves pregnant women in their first trimester who conceived through IVF (in vitro fertilization), along with their partners. **You may be eligible if...** - You are a pregnant woman in your first trimester - You conceived through IVF (FIVET technique) — either with your own eggs or through egg donation - You are carrying a single baby (not twins or more) - Your partner is also willing to participate **You may NOT be eligible if...** - Either parent is under 18 - You conceived using donor sperm - You conceived without IVF - You have high blood pressure, an endocrine disorder, or immune system condition during this pregnancy - You regularly use medications like anti-inflammatories, antidepressants, or steroids during pregnancy - You smoke, drink alcohol, or use substances during pregnancy - You have a psychiatric disorder beyond anxiety or depression - Your pregnancy is complicated, or your baby is born premature or with health problems at birth Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDiagnostic procedures

psychological and biological multimodal assessment of stress


Locations(1)

Ospedale Papa Giovanni XXIII

Bergamo, Bergamo, Italy

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NCT07408453