| NCT ID | NCT07408453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Pregnancy and Medically Assisted Reproduction |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-04 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07408453 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pregnancy and Medically Assisted Reproduction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07408453 currently recruiting?
Yes, NCT07408453 is actively recruiting participants. Contact the research team at alessandra.frigerio@lanostrafamiglia.it for enrollment information.
Where is the NCT07408453 trial being conducted?
This trial is being conducted at Bergamo, Italy.
Who is sponsoring the NCT07408453 clinical trial?
NCT07408453 is sponsored by IRCCS Eugenio Medea. The trial plans to enroll 100 participants.