InfertilityTCA2NCT02029365
Transversal, Controlled and Not Randomized Study, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women
A study testing Autoquestionnary and semi-structured interview in people with Infertility and Eating Disorders, run by Nantes University Hospital at 1 site in France.
Trial summary
In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility remains " unexplained" . Among the causes of female infertility , there are the eating disorders, as well as sexual disorders , these two cases may be linked. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Eating Disorders
- What is being tested?
- Autoquestionnary and semi-structured interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Major
- In a relationship
- Infertile (WHO criteria)
- Consultant in the Department of infertility (BMDR) for AMP
- Understanding of French, literate
- Agree to participate in the study
Who cannot join
- Man
- Minor
- Pregnancy at the time of assessment
- Exclusive Infertility spouse
- Disorders of higher functions (severe cognitive impairment or confusion) or psychosis (hallucinations, delusional syndrome)
- Major protected
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center Study, Transversal, Controlled and Not Randomized, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women
In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility remains " unexplained" . Among the causes of female infertility , there are the eating disorders, as well as sexual disorders , these two cases may be linked. In addition, data from the literature seem to suggest that beyond a diagnosis of eating disorders, the feeding behavior of infertile women is more often disturbed than the general population. Moreover, the notions of desire for a child and maternal representations seem essential to address in the comprehensive care of women with infertility but also TCA integrating all conflicting issues reactivated at the time of motherhood. However, little work has been done on this subject. Thus, we propose a study on the desire for children and the eating disorders to infertile women, to update epidemiological data, but also to better characterize this particular patient population. Perspectives of this work are to improve screening measures and support through a joint work of doctors reproductive and psychiatrists.
- Conditions
- Infertility, Eating Disorders
- Being tested
- Autoquestionnary, semi-structured interview
- Keywords
- Infertility, desire for children, eating disorder, anorexia nervosa, bulimia nervosa, eating disorders not otherwise specified
- Medical subject headings
- Infertility, Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoquestionnaryOther
autoquestionnary completed during the consultation for infertility
semi-structured interviewOther
phone interview
| Study group | Role | What they receive |
|---|---|---|
| Without eating disorders | Other | Women consulting for infertility but without diagnosis of eating disorder. Receives: Other: Autoquestionnary |
| With Eating disorders | Other | Womenconsulting for infertility for which eating disorder is diagnosed. Receives: Other: Autoquestionnary; Other: semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children desire
Questionnaire scores of children desire (Fragebogen zum Kinderwunsch) , according to three dimensions:
- Improved self-esteem''
- Emotional Stabilization
- Ambivalence
Measured: 30 days
Secondary outcomes (4)
Dysmorphic
score Body Shape Questionnaire (BSQ)
Measured: 30 days
Sexuality
History Questionnaire score Sexual (QHS)
Measured: 30 days
Anxiety and depression
score on the Hospital Anxiety and Depression Scale (HAD)
Measured: 30 days
Quality of life questionnaire
Quality of life questionnaire score FertiQol internationnal
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie GRALL-BRONNEC, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029365
- Sponsor's protocol ID
- RC13_0449
- Acronym
- TCA2
- Status last verified
- Mar 2015
- First submitted
- 6 Jan 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Study, Transversal, Controlled and Not Randomized, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women
- ClinicalTrials.gov ID
- NCT02029365
- Acronym / sponsor ID
- TCA2 / RC13_0449
- Conditions
- Infertility, Eating Disorders
- Keywords
- Infertility, desire for children, eating disorder, anorexia nervosa, bulimia nervosa, eating disorders not otherwise specified
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Jan 2014 (estimated)
- 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.
In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility remains " unexplained" . Among the causes of female infertility , there are the eating disorders, as well as sexual disorders , these two cases may be linked. In addition, data from the literature seem to suggest that beyond a diagnosis of eating disorders, the feeding behavior of infertile women is more often disturbed than the general population. Moreover, the notions of desire for a child and maternal representations seem essential to address in the comprehensive care of women with infertility but also TCA integrating all conflicting issues reactivated at the time of motherhood. However, little work has been done on this subject. Thus, we propose a study on the desire for children and the eating disorders to infertile women, to update epidemiological data, but also to better characterize this particular patient population. Perspectives of this work are to improve screening measures and support through a joint work of doctors reproductive and psychiatrists.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without eating disorders | Other | Other: AutoquestionnaryWomen consulting for infertility but without diagnosis of eating disorder. |
| With Eating disorders | Other | Other: Autoquestionnary, Other: semi-structured interviewWomenconsulting for infertility for which eating disorder is diagnosed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women
- Major
- In a relationship
- Infertile (WHO criteria)
- Consultant in the Department of infertility (BMDR) for AMP
Key exclusion criteria (6 listed)
- Man
- Minor
- Pregnancy at the time of assessment
- Exclusive Infertility spouse
- Disorders of higher functions (severe cognitive impairment or confusion) or psychosis (hallucinations, delusional syndrome)
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 |
|---|---|---|
| Autoquestionnaryautoquestionnary completed during the consultation for infertility | Other | With Eating disorders, Without eating disorders |
| semi-structured interviewphone interview | Other | With Eating disorders |
Primary outcome
Children desire
Time frame: 30 days
Questionnaire scores of children desire (Fragebogen zum Kinderwunsch) , according to three dimensions: * Improved self-esteem'' * Emotional Stabilization * Ambivalence
4 secondary outcomes
Dysmorphic
Time frame: 30 days
Sexuality
Time frame: 30 days
Anxiety and depression
Time frame: 30 days
Quality of life questionnaire
Time frame: 30 days
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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.
Marie GRALL-BRONNEC principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autoquestionnary and semi-structured interview in people with Infertility and Eating Disorders, run by Nantes University Hospital at 1 site in France.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children desire (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2015.