Infertility, FemaleACESINCT05952427
Adverse Childhood Experiences and Infertility : ACESI
An observational study of Infertility, Female and Trauma, Psychological, run by University Hospital, Grenoble.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Trauma, Psychological, Child Development
- What is being tested?
- ACE Questionnaire
- How many people
- 332 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- Patients who do not speak French well enough to benefit from clear and intelligible information
- Patients refusing to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Infertility, Female, Trauma, Psychological, Child Development, Child Abuse, Health Behavior
- Being tested
- ACE Questionnaire
- Keywords
- psychologic, traumatism, women, sterility, infertility, abuse, development, gynecologist
- Medical subject headings
- Infertility, Female, Psychological Trauma, Health Behavior, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE QuestionnaireOther
The only intervention consists of completing the validated ACE questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: ACE Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the 1 day of the inclusion, starting from the first of august 9:00 am
Secondary outcomes (1)
Description of types of adverse experiences
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).
Measured: the 1 day of the inclusion, starting from the first of august 9:00 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cross-sectional
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952427
- Sponsor's protocol ID
- 2023-A00776-39
- Acronym
- ACESI
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31104722Chrousos 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.
PubMed 9696732Harris 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.
PubMed 30016439Liebermann 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.
PubMed 29947745Jacobs 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.
PubMed 25826282Schliep 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.
PubMed 27334336
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Childhood Experiences and Infertility : ACESI
- ClinicalTrials.gov ID
- NCT05952427
- Acronym / sponsor ID
- ACESI / 2023-A00776-39
- Conditions
- Infertility, Female, Trauma, Psychological, Child Development, Child Abuse, Health Behavior
- Keywords
- psychologic, traumatism, women, sterility, infertility, abuse, development, gynecologist
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 19 Jul 2023 (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.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infertile women | – | Other: ACE QuestionnaireAny patient consulting for the first time at the Grenoble University Hospital in a context of infertility, between 18 and 43 years old |
| Non-infertile women | – | Other: ACE QuestionnaireAny patient consulting her gynecologist in town for a reason other than infertility, and having no known infertility, between 18 and 43 years old |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who do not speak French well enough to benefit from clear and intelligible information
- Patients refusing to participate in the study
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 |
|---|---|---|
| ACE QuestionnaireThe only intervention consists of completing the validated ACE questionnaire | Other | Infertile women, Non-infertile women |
Primary outcome
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
Time frame: 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
1 secondary outcome
Description of types of adverse experiences
Time frame: the 1 day of the inclusion, starting from the first of august 9:00 am
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 31104722Felitti 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.
- Background: PubMed 9696732Chrousos 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.
- Background: PubMed 30016439Harris 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.
- Background: PubMed 29947745Liebermann 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.
- Background: PubMed 25826282Jacobs 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.
- Background: PubMed 27334336Schliep 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Trauma, Psychological, run by University Hospital, Grenoble.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascale Hoffmann, Pr (04 76 76 59 09, phoffmann@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: the 1 day of the inclusion, starting from the first of august 9:00 am). 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 NCT05952427, which also lists 6 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 19 Jul 2023.