Pregnancy and Medically Assisted Reproduction
Conditions
Keywords
antenatal anxiety, antenatal depression, salivary cortisol, salivary alpha amylase, medically assisted reproduction
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)
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.
Interventions
psychological and biological multimodal assessment of stress
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Anxiety | Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth. | Levels of anxiety in mothers during pregnancy and at birth, measured using the STAI |
| Maternal Depression | Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth. | Levels of depressive symptoms in mothers during pregnancy and at birth, measured using the EPDS |
| Maternal salivary cortisol | 3rd trimester (34th-36th week of pregnancy) | Salivary cortisol levels measured at three time points across two consecutive days in late pregnancy, reflecting HPA axis |
| Maternal salivary alpha amylase | 3rd trimester (34th-36th week of pregnancy). | Salivary alpha-amylase levels measured at three time points across two consecutive days in late pregnancy, reflecting sympathetic nervous system activity. |
| Paternal Anxiety | 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth | Levels of anxiety during pregnancy and at birth measured using the STAI |
| Paternal depression | 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth. | Levels of depressive symptoms in fathers during pregnancy and at birth, measured using the EPDS |
| Neonatal Outcomes | At birth | Gestational age, birth weight, length, head circumference, and any perinatal complications recorded at birth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy-Specific Distress (maternal) | 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week) | Levels of pregnancy-related stress assessed using the NuPDQ questionnaire |
| Prenatal Emotional Availability | 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week) | Quality of the mother's emotional availability and bonding with the fetus, measured using the Pre EA-SR questionnaire |
| Perceived Social Support | 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth. | Parental perception of support from family, friends, and significant others, measured using the MSPSS questionnaire. |
| Parental Self-Efficacy | 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth. | General sense of self-efficacy assessed in both parents using the GSE questionnaire |
| Infertility-Related Experiences and Psychological Support | 3rd trimester (34th-36th week | Maternal report on the impact of medically assisted reproduction on daily life and the psychological support received, collected via an ad hoc questionnaire |
Countries
Italy