Antenatal Stress and Infants In MAR

NCT07408453 | Recruiting

• 1 other identifier: 222/24
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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:

• 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)

Conditions

Pregnancy and Medically Assisted Reproduction

Keywords

antenatal anxiety; antenatal depression; salivary cortisol; salivary alpha amylase; medically assisted reproduction

Outcome Measures

Primary Outcomes (7)

• Maternal Anxiety

  Levels of anxiety in mothers during pregnancy and at birth, measured using the STAI

  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

  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

  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.

  3rd trimester (34th-36th week of pregnancy).

• Paternal Anxiety

  Levels of anxiety during pregnancy and at birth measured using the STAI

  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

  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.

  At birth

Secondary Outcomes (5)

• Pregnancy-Specific Distress (maternal)

  1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)

• Prenatal Emotional Availability

  1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)

• Perceived Social Support

  1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.

• Parental Self-Efficacy

  1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.

• Infertility-Related Experiences and Psychological Support

  3rd trimester (34th-36th week

Study Arms (2)

Homologous fertilization group

Mother shares genetic heritage with the child

Other: Diagnostic procedures

Heterologous fertilization group

Mother does not share genetic heritage with the child (oocyte donation)

Other: Diagnostic procedures

Interventions

Diagnostic procedures OTHER

psychological and biological multimodal assessment of stress

Heterologous fertilization group; Homologous fertilization group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on biological sex necessary for the study and is not restricted by participants' gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• A.O. Ospedale Papa Giovanni XXIII: collaborator

Study Sites (1)

Ospedale Papa Giovanni XXIII

Bergamo, Bergamo, 24127, Italy

RECRUITING

Related Publications (10)

• 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.

  PMID: 37866288 BACKGROUND

• Salevaara 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.

  PMID: 29975790 BACKGROUND

• Rice 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.

  PMID: 19476689 BACKGROUND

• Nazzari 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.

  PMID: 30497017 BACKGROUND

• Mascarenhas 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.

  PMID: 28942045 BACKGROUND

• Lobel 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.

  PMID: 18823187 BACKGROUND

• Gilles 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.

  PMID: 29783163 BACKGROUND

• Garcia-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.

  PMID: 29796614 BACKGROUND

• Caparros-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.

  PMID: 30810358 BACKGROUND

• Bolten 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.

  PMID: 20872154 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

salivary cortisol and alpha amylase

Central Study Contacts

Alessandra Frigerio, PhD

CONTACT

+39031877595; alessandra.frigerio@lanostrafamiglia.it

Simone Forni

CONTACT

+39031877111; simone.forni@lanostrafmiglia.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

IT (1)