Pregnancy and Medically Assisted ReproductionSARANCT07408453
Antenatal Stress and Infants In MAR
An observational study of Pregnancy and Medically Assisted Reproduction, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnancy and Medically Assisted Reproduction
- What is being tested?
- Diagnostic procedures
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Couples from Lombardy, Italy, who conceived through medically assisted reproduction are recruited via fertility centers. The study includes first-trimester pregnant women and their male partners with singleton pregnancies.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Papa Giovanni XXIII
Bergamo, Bergamo, 24127
Head of the Assisted Reproduction Unit, MD, +39035267111, ffusi@asst-pg23.it
About this study
Official title: The Effects of Antenatal Stress on the Newborn in Medically Assisted Reproduction: the SARA 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:
Read more
- How do psychological and biological indicators of stress manifest during pregnancy in women who have undergone medically assisted reproduction?
- Is prenatal maternal stress associated with neonatal health outcomes independently of genetic factors?
- 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)
Read the 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.
- Being tested
- Diagnostic procedures
- Keywords
- antenatal anxiety, antenatal depression, salivary cortisol, salivary alpha amylase, medically assisted reproduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic proceduresOther
psychological and biological multimodal assessment of stress
| Study group | Role | What they receive |
|---|---|---|
| Homologous fertilization group | Mother shares genetic heritage with the child Receives: Other: Diagnostic procedures | |
| Heterologous fertilization group | Mother does not share genetic heritage with the child (oocyte donation) Receives: Other: Diagnostic procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Anxiety
Levels of anxiety in mothers during pregnancy and at birth, measured using the STAI
Measured: Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
Maternal Depression
Levels of depressive symptoms in mothers during pregnancy and at birth, measured using the EPDS
Measured: Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
Maternal salivary cortisol
Salivary cortisol levels measured at three time points across two consecutive days in late pregnancy, reflecting HPA axis
Measured: 3rd trimester (34th-36th week of pregnancy)
Maternal salivary alpha amylase
Salivary alpha-amylase levels measured at three time points across two consecutive days in late pregnancy, reflecting sympathetic nervous system activity.
Measured: 3rd trimester (34th-36th week of pregnancy).
Paternal Anxiety
Levels of anxiety during pregnancy and at birth measured using the STAI
Measured: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth
Paternal depression
Levels of depressive symptoms in fathers during pregnancy and at birth, measured using the EPDS
Measured: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
Neonatal Outcomes
Gestational age, birth weight, length, head circumference, and any perinatal complications recorded at birth.
Measured: At birth
Secondary outcomes (5)
Pregnancy-Specific Distress (maternal)
Levels of pregnancy-related stress assessed using the NuPDQ questionnaire
Measured: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)
Prenatal Emotional Availability
Quality of the mother's emotional availability and bonding with the fetus, measured using the Pre EA-SR questionnaire
Measured: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)
Perceived Social Support
Parental perception of support from family, friends, and significant others, measured using the MSPSS questionnaire.
Measured: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
Parental Self-Efficacy
General sense of self-efficacy assessed in both parents using the GSE questionnaire
Measured: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
Infertility-Related Experiences and Psychological Support
Maternal report on the impact of medically assisted reproduction on daily life and the psychological support received, collected via an ad hoc questionnaire
Measured: 3rd trimester (34th-36th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pregnancy and Medically Assisted ReproductionStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- A.O. Ospedale Papa Giovanni XXIII
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408453
- Sponsor's protocol ID
- 222/24
- Acronym
- SARA
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang Z, Wang X, Wang M, Yan S, Wu F, Zhang F. Trajectory of prenatal anxiety and depression and its association with fetal growth development. Early Hum Dev. 2023 Dec;187:105875. doi: 10.1016/j.earlhumdev.2023.105875. Epub 2023 Oct 17.
PubMed 37866288Salevaara M, Punamaki RL, Unkila-Kallio L, Vanska M, Tulppala M, Tiitinen A. The mental health of mothers and fathers during pregnancy and early parenthood after successful oocyte donation treatment: A nested case-control study. Acta Obstet Gynecol Scand. 2018 Dec;97(12):1478-1485. doi: 10.1111/aogs.13421. Epub 2018 Aug 6.
PubMed 29975790Rice F, Harold GT, Boivin J, van den Bree M, Hay DF, Thapar A. The links between prenatal stress and offspring development and psychopathology: disentangling environmental and inherited influences. Psychol Med. 2010 Feb;40(2):335-45. doi: 10.1017/S0033291709005911. Epub 2009 May 29.
PubMed 19476689Nazzari S, Fearon P, Rice F, Dottori N, Ciceri F, Molteni M, Frigerio A. Beyond the HPA-axis: Exploring maternal prenatal influences on birth outcomes and stress reactivity. Psychoneuroendocrinology. 2019 Mar;101:253-262. doi: 10.1016/j.psyneuen.2018.11.018. Epub 2018 Nov 14.
PubMed 30497017Mascarenhas M, Sunkara SK, Antonisamy B, Kamath MS. Higher risk of preterm birth and low birth weight following oocyte donation: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Nov;218:60-67. doi: 10.1016/j.ejogrb.2017.09.015. Epub 2017 Sep 19.
PubMed 28942045Lobel M, Cannella DL, Graham JE, DeVincent C, Schneider J, Meyer BA. Pregnancy-specific stress, prenatal health behaviors, and birth outcomes. Health Psychol. 2008 Sep;27(5):604-15. doi: 10.1037/a0013242.
PubMed 18823187Gilles M, Otto H, Wolf IAC, Scharnholz B, Peus V, Schredl M, Sutterlin MW, Witt SH, Rietschel M, Laucht M, Deuschle M. Maternal hypothalamus-pituitary-adrenal (HPA) system activity and stress during pregnancy: Effects on gestational age and infant's anthropometric measures at birth. Psychoneuroendocrinology. 2018 Aug;94:152-161. doi: 10.1016/j.psyneuen.2018.04.022. Epub 2018 Apr 22.
PubMed 29783163Garcia-Blanco A, Diago V, Hervas D, Ghosn F, Vento M, Chafer-Pericas C. Anxiety and depressive symptoms, and stress biomarkers in pregnant women after in vitro fertilization: a prospective cohort study. Hum Reprod. 2018 Jul 1;33(7):1237-1246. doi: 10.1093/humrep/dey109.
PubMed 29796614Caparros-Gonzalez RA, Romero-Gonzalez B, Quesada-Soto JM, Gonzalez-Perez R, Marinas-Lirola JC, Peralta-Ramirez MI. Maternal hair cortisol levels affect neonatal development among women conceiving with assisted reproductive technology. J Reprod Infant Psychol. 2019 Nov;37(5):480-498. doi: 10.1080/02646838.2019.1578949. Epub 2019 Feb 27.
PubMed 30810358Bolten MI, Wurmser H, Buske-Kirschbaum A, Papousek M, Pirke KM, Hellhammer D. Cortisol levels in pregnancy as a psychobiological predictor for birth weight. Arch Womens Ment Health. 2011 Feb;14(1):33-41. doi: 10.1007/s00737-010-0183-1. Epub 2010 Sep 25.
PubMed 20872154
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Antenatal Stress on the Newborn in Medically Assisted Reproduction: the SARA Study
- ClinicalTrials.gov ID
- NCT07408453
- Acronym / sponsor ID
- SARA / 222/24
- Keywords
- antenatal anxiety, antenatal depression, salivary cortisol, salivary alpha amylase, medically assisted reproduction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- A.O. Ospedale Papa Giovanni XXIII
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How do psychological and biological indicators of stress manifest during pregnancy in women who have undergone medically assisted reproduction?
- Is prenatal maternal stress associated with neonatal health outcomes independently of genetic factors?
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homologous fertilization group | – | Other: Diagnostic proceduresMother shares genetic heritage with the child |
| Heterologous fertilization group | – | Other: Diagnostic proceduresMother does not share genetic heritage with the child (oocyte donation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Couples from Lombardy, Italy, who conceived through medically assisted reproduction are recruited via fertility centers. The study includes first-trimester pregnant women and their male partners with singleton pregnancies.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic procedurespsychological and biological multimodal assessment of stress | Other | Heterologous fertilization group, Homologous fertilization group |
Primary outcome
Maternal Anxiety
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At birth
Gestational age, birth weight, length, head circumference, and any perinatal complications recorded at birth.
5 secondary outcomes
Pregnancy-Specific Distress (maternal)
Time frame: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)
Prenatal Emotional Availability
Time frame: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)
Perceived Social Support
Time frame: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
Parental Self-Efficacy
Time frame: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
Infertility-Related Experiences and Psychological Support
Time frame: 3rd trimester (34th-36th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 37866288Yang Z, Wang X, Wang M, Yan S, Wu F, Zhang F. Trajectory of prenatal anxiety and depression and its association with fetal growth development. Early Hum Dev. 2023 Dec;187:105875. doi: 10.1016/j.earlhumdev.2023.105875. Epub 2023 Oct 17.
- Background: PubMed 29975790Salevaara M, Punamaki RL, Unkila-Kallio L, Vanska M, Tulppala M, Tiitinen A. The mental health of mothers and fathers during pregnancy and early parenthood after successful oocyte donation treatment: A nested case-control study. Acta Obstet Gynecol Scand. 2018 Dec;97(12):1478-1485. doi: 10.1111/aogs.13421. Epub 2018 Aug 6.
- Background: PubMed 19476689Rice F, Harold GT, Boivin J, van den Bree M, Hay DF, Thapar A. The links between prenatal stress and offspring development and psychopathology: disentangling environmental and inherited influences. Psychol Med. 2010 Feb;40(2):335-45. doi: 10.1017/S0033291709005911. Epub 2009 May 29.
- Background: PubMed 30497017Nazzari S, Fearon P, Rice F, Dottori N, Ciceri F, Molteni M, Frigerio A. Beyond the HPA-axis: Exploring maternal prenatal influences on birth outcomes and stress reactivity. Psychoneuroendocrinology. 2019 Mar;101:253-262. doi: 10.1016/j.psyneuen.2018.11.018. Epub 2018 Nov 14.
- Background: PubMed 28942045Mascarenhas M, Sunkara SK, Antonisamy B, Kamath MS. Higher risk of preterm birth and low birth weight following oocyte donation: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Nov;218:60-67. doi: 10.1016/j.ejogrb.2017.09.015. Epub 2017 Sep 19.
- Background: PubMed 18823187Lobel M, Cannella DL, Graham JE, DeVincent C, Schneider J, Meyer BA. Pregnancy-specific stress, prenatal health behaviors, and birth outcomes. Health Psychol. 2008 Sep;27(5):604-15. doi: 10.1037/a0013242.
- Background: PubMed 29783163Gilles M, Otto H, Wolf IAC, Scharnholz B, Peus V, Schredl M, Sutterlin MW, Witt SH, Rietschel M, Laucht M, Deuschle M. Maternal hypothalamus-pituitary-adrenal (HPA) system activity and stress during pregnancy: Effects on gestational age and infant's anthropometric measures at birth. Psychoneuroendocrinology. 2018 Aug;94:152-161. doi: 10.1016/j.psyneuen.2018.04.022. Epub 2018 Apr 22.
- Background: PubMed 29796614Garcia-Blanco A, Diago V, Hervas D, Ghosn F, Vento M, Chafer-Pericas C. Anxiety and depressive symptoms, and stress biomarkers in pregnant women after in vitro fertilization: a prospective cohort study. Hum Reprod. 2018 Jul 1;33(7):1237-1246. doi: 10.1093/humrep/dey109.
- Background: PubMed 30810358Caparros-Gonzalez RA, Romero-Gonzalez B, Quesada-Soto JM, Gonzalez-Perez R, Marinas-Lirola JC, Peralta-Ramirez MI. Maternal hair cortisol levels affect neonatal development among women conceiving with assisted reproductive technology. J Reprod Infant Psychol. 2019 Nov;37(5):480-498. doi: 10.1080/02646838.2019.1578949. Epub 2019 Feb 27.
- Background: PubMed 20872154Bolten MI, Wurmser H, Buske-Kirschbaum A, Papousek M, Pirke KM, Hellhammer D. Cortisol levels in pregnancy as a psychobiological predictor for birth weight. Arch Womens Ment Health. 2011 Feb;14(1):33-41. doi: 10.1007/s00737-010-0183-1. Epub 2010 Sep 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Medically Assisted Reproduction, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Frigerio, PhD (+39031877595, alessandra.frigerio@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Anxiety (time frame: Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07408453, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.