Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
332 participants
OBSERVATIONAL
2023-08-01
2024-07-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
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
ACE Questionnaire
The only intervention consists of completing the validated ACE questionnaire
Interventions
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ACE Questionnaire
The only intervention consists of completing the validated ACE questionnaire
Eligibility Criteria
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Inclusion Criteria
. - 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 refusing to participate in the study
18 Years
43 Years
FEMALE
Yes
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2023-A00776-39
Identifier Type: -
Identifier Source: org_study_id
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