Recruiting

Antenatal Stress and Infants In MAR

ClinicalTrials.gov IDNCT07408453

PhaseNot Applicable

Enrollment100

SponsorIRCCS Eugenio Medea

Age18 Years

SexALL

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Conditions studied

Pregnancy and Medically Assisted Reproduction

About this study

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)

Interventions

Other: Diagnostic procedures — psychological and biological multimodal assessment of stress

Primary outcomes

Maternal Anxiety (Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.)
Maternal Depression (Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.)
Maternal salivary cortisol (3rd trimester (34th-36th week of pregnancy))
Maternal salivary alpha amylase (3rd trimester (34th-36th week of pregnancy).)
Paternal Anxiety (1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth)
Paternal depression (1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.)
Neonatal Outcomes (At birth)

Eligibility information

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.

Study locations

Ospedale Papa Giovanni XXIII, Bergamo, Bergamo 24127 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.