Antenatal Stress and Infants In MAR

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Eugenio Medea

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Parents under 18 years of age.

Pregnancy achieved through heterologous assisted reproduction via donor sperm.

Pregnancy achieved without FIVET techniques.

Maternal hypertension during pregnancy.

Trial design

Treatments tested in this trial

  • Diagnostic procedures

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS Eugenio Medea

Lead sponsor

A.O. Ospedale Papa Giovanni XXIII

Collaborator