NCT07408453

Antenatal Stress and Infants In MAR

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Eugenio Medea · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Detailed description

This observational, longitudinal, and multidisciplinary study investigates how prenatal psychological and biological stress affects neonatal outcomes in couples who conceived through medically assisted reproduction. The study employs a cross-fostering design, comparing mother-infant diads who are genetically related with those who are not. This allows researchers to distinguish the effects of prenatal stress from genetic influences. Data from this study may also be compared with findings from a previous study by our research group ("EDI Study"; Nazzari et al., 2019, 2020a, 2020b) for common objectives. The study is non-commercial and conducted on a not-for-profit basis. Participants are recruited through fertility centers, where physicians present the study to prospective parents during routine visits, supported by brochures and informational materials. Mothers undergo an initial screening using the Quick SCID-5 to exclude psychiatric disorders other than anxiety and depression, and complete a health questionnaire to assess physical status during pregnancy. Eligible mothers and fathers then participate in several phases of data collection throughout pregnancy and at birth. Both parents complete online questionnaires assessing anxiety, depressive symptoms, perceived social support, and general self-efficacy. Mothers additionally complete pregnancy-specific measures, including the NuPDQ to evaluate prenatal distress and the Pre EA-SR to assess prenatal emotional availability and bonding with the fetus. In the third trimester, mothers also collect saliva samples at three points during the day across two consecutive days to measure stress-related biological markers (cortisol and alpha-amylase). At birth, neonatal outcomes-including gestational age, weight, length, head circumference, and any perinatal complications-are recorded. Mothers also provide information about the impact of medically assisted reproduction on daily life and the psychological support they received during pregnancy. The enrollment period for each participant lasts approximately 8 months, from recruitment in the first two months of pregnancy until childbirth. The overall study duration is 36 months. Data analysis will employ multiple regression and hierarchical linear models to account for both primary and secondary outcomes and handle missing data appropriately. This study will provide valuable insights into how prenatal stress manifests behaviorally, psychologically, and physiologically in parents who have undergone assisted reproduction and how it relates to neonatal outcomes. Findings could inform early interventions to support families in these populations from the very first stages of pregnancy.

Conditions

• Pregnancy and Medically Assisted Reproduction

Interventions

Type	Name	Description
OTHER	Diagnostic procedures	psychological and biological multimodal assessment of stress

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: Italy