Adverse Childhood Experiences and Infertility : ACESI

NCT05952427 | Unknown

• 1 other identifier: 2023-A00776-39
• Study Type: observational
• Target: 332
• Locations: 0 countries
• Sites: N/A

Brief Summary

Adverse childhood experiences can have powerful effects on health and quality of life in adulthood. Thus, having a history of childhood trauma, before the age of 18 (physical aggression, sexual abuse, death of a close person, etc.) significantly increases the risk of having cancer, cardiovascular disease, psychological damage , or earlier mortality. Validated scores allow the evaluation of the importance of adverse childhood experiences, in particular the ACE score (adverse childhood experiences) published by Felitti. Studies on the subject show a dose-response relationship between exposure to adverse childhood experiences and negative outcomes in terms of health and well-being. The physiopathological tracks to explain the occurrence of somatic pathologies in adulthood include the observation of a state of hyper-activation of the HPA axis that persists in adulthood; modulations of immunity, but also epigenetic modifications. Some data are available on the associations between childhood trauma and obstetric risks, with a significant increase in the risk of preterm delivery and fetal death in utero. Primary objective : 1a) To study the prevalence of adverse childhood experiences (ACE) in women consulting for the first time in an PMA service for the desire to become pregnant, and 1b) To study the association between adverse childhood experiences and infertility in adulthood, by comparing infertile women with nulliparous control women in the general population consulting for their classic gynecological follow-up.

Conditions

Infertility, Female; Trauma, Psychological; Child Development; Child Abuse; Health Behavior

Keywords

psychologic; traumatism; women; sterility; infertility; abuse; development; gynecologist

Outcome Measures

Primary Outcomes (1)

• Prevalence estimated by the proportion of patients with a high Adverse Childhood Experiences (ACE) score defined by a score ≥ 4, with Odds ratio and its 95% CI

  Prevalence of adverse childhood experiences (ACE) in women consulting for the first time in a PMA service for pregnancy desire, compared to women in the general population

  the 1 day of the inclusion, starting from the first of august 9:00 am

Secondary Outcomes (1)

• Description of types of adverse experiences

  the 1 day of the inclusion, starting from the first of august 9:00 am

Study Arms (2)

Infertile women

Any patient consulting for the first time at the Grenoble University Hospital in a context of infertility, between 18 and 43 years old

Other: ACE Questionnaire

Non-infertile women

Any patient consulting her gynecologist in town for a reason other than infertility, and having no known infertility, between 18 and 43 years old

Other: ACE Questionnaire

Interventions

ACE Questionnaire OTHER

The only intervention consists of completing the validated ACE questionnaire

Infertile women; Non-infertile women

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: Women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertile adult women, nulliparous, aged 18 to 43, consulting for the first time at the clinical-biological center of AMP of the CHU of Grenoble Alpes for desire of pregnancy within the framework of a heterosexual couple * Controls: Women of legal age, nulliparous, in the general population consulting their city gynecologist during the same study period, aged 18 to 43 and a priori without known infertility * Case: Infertile adult women, nulliparous, aged 18 to 43, consulting for the first time at the clinical-biological center of AMP of the CHU of Grenoble Alpes for desire of pregnancy within the framework of a heterosexual couple

You may qualify if:

• \- Case: Infertile adult women, nulliparous, aged 18 to 43, consulting for the first time at the clinical-biological center of AMP of the CHU of Grenoble Alpes for desire of pregnancy within the framework of a heterosexual couple
• Controls: Women of legal age, nulliparous, in the general population consulting their city gynecologist during the same study period, aged 18 to 43 and a priori without known infertility

You may not qualify if:

• Patients who do not speak French well enough to benefit from clear and intelligible information
• Patients refusing to participate in the study

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Related Publications (6)

• Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. REPRINT OF: Relationship of Childhood Abuse and Household Dysfunction to Many of the Leading Causes of Death in Adults: The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 2019 Jun;56(6):774-786. doi: 10.1016/j.amepre.2019.04.001.

  PMID: 31104722 BACKGROUND

• Chrousos GP, Torpy DJ, Gold PW. Interactions between the hypothalamic-pituitary-adrenal axis and the female reproductive system: clinical implications. Ann Intern Med. 1998 Aug 1;129(3):229-40. doi: 10.7326/0003-4819-129-3-199808010-00012.

  PMID: 9696732 BACKGROUND

• Harris HR, Wieser F, Vitonis AF, Rich-Edwards J, Boynton-Jarrett R, Bertone-Johnson ER, Missmer SA. Early life abuse and risk of endometriosis. Hum Reprod. 2018 Sep 1;33(9):1657-1668. doi: 10.1093/humrep/dey248.

  PMID: 30016439 BACKGROUND

• Liebermann C, Kohl Schwartz AS, Charpidou T, Geraedts K, Rauchfuss M, Wolfler M, von Orelli S, Haberlin F, Eberhard M, Imesch P, Imthurn B, Leeners B. Maltreatment during childhood: a risk factor for the development of endometriosis? Hum Reprod. 2018 Aug 1;33(8):1449-1458. doi: 10.1093/humrep/dey111.

  PMID: 29947745 BACKGROUND

• Jacobs MB, Boynton-Jarrett RD, Harville EW. Adverse childhood event experiences, fertility difficulties and menstrual cycle characteristics. J Psychosom Obstet Gynaecol. 2015;36(2):46-57. doi: 10.3109/0167482X.2015.1026892. Epub 2015 Mar 31.

  PMID: 25826282 BACKGROUND

• Schliep KC, Mumford SL, Johnstone EB, Peterson CM, Sharp HT, Stanford JB, Chen Z, Backonja U, Wallace ME, Buck Louis GM. Sexual and physical abuse and gynecologic disorders. Hum Reprod. 2016 Aug;31(8):1904-12. doi: 10.1093/humrep/dew153. Epub 2016 Jun 22.

  PMID: 27334336 BACKGROUND

MeSH Terms

Conditions

Infertility, Female; Psychological Trauma; Health Behavior; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Central Study Contacts

Pascale Hoffmann, Pr

CONTACT

04 76 76 59 09; phoffmann@chu-grenoble.fr

Study Design

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

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 19, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: July 1, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share