Adverse Childhood Experiences and Infertility : ACESI

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05952427
Collaborator
(none)
332
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ACE Questionnaire

Detailed Description

Procedures for recruiting participants:

Cases (infertile women): A poster presenting the study will be put up in the waiting room of the PMA center of the Grenoble University Hospital. The information and non-objection letter as well as the ACE questionnaire will be made available to them in the waiting room. If the patient agrees to participate, she will complete the questionnaire completely anonymously and submit it to the secretariat.

Witnesses: A poster presenting the study will be put up in gynecology practices (Non-exhaustive list: Cabinet Gynelac of Dr Flandrin in Aix les Bains, Cabinet of Dr Chabre Groupe Hospitalier Mutualiste in Grenoble, Cabinet of Dr Fragai in Voiron , Cabinet of Dr. Biot at the Clinique des Cèdres in Echirolles, etc.) thus any woman consulting for a gynecological follow-up will be able to find out about the study.

The information and non-objection letter as well as the ACE questionnaire will be made available to them in the waiting room. If the patient agrees to participate, she will complete the questionnaire completely anonymously and submit it to the secretariat.

After inclusion, case women and control women will benefit from the usual care in the PMA center, or by their usual gynecologist. The participation of subjects in this study will in no way modify their care. The participation of the subjects will be limited to filling out the ACE questionnaire. No additional visit, no sampling or additional treatment other than those commonly carried out for the care of infertile women is carried out for this study.

If after answering the questionnaire, patients feel the need, they can be directed to the "Maison Des Femmes" in Grenoble, where they can benefit from appropriate multidisciplinary care (doctors, psychologists, physiotherapists, etc.).

Modalities of information and traceability of the non-opposition:

Cases (infertile women): the information letter will be available in the waiting room. The questionnaire being anonymous, there will be no possibility of opposition after having answered the questionnaire.

Witnesses: the newsletter will be available in the waiting room. The questionnaire being anonymous, there will be no possibility of opposition after having answered the questionnaire.

Study Design

Study Type:
Observational
Anticipated Enrollment :
332 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Adverse Childhood Experiences and Infertility : ACESI
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
The only intervention consists of completing the validated 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
The only intervention consists of completing the validated ACE questionnaire

Outcome Measures

Primary Outcome Measures

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

    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

Secondary Outcome Measures

  1. Description of types of adverse experiences [the 1 day of the inclusion, starting from the first of august 9:00 am]

    Description of unfavorable childhood experiences among women consulting for pregnancy in an PMA service, using a validated score: the ACE score (CDC, 2021; Felitti et al., 1998).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 43 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Patients who do not speak French well enough to benefit from clear and intelligible information

  • Patients refusing to participate in the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT05952427
Other Study ID Numbers:
  • 2023-A00776-39
First Posted:
Jul 19, 2023
Last Update Posted:
Jul 19, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Grenoble
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2023