Back to resultsTransversal, Controlled and Not Randomized Study, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women (TCA2)
Primary Purpose
Infertility, Eating Disorders
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Autoquestionnary
semi-structured interview
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility focused on measuring Infertility, desire for children, eating disorder, anorexia nervosa, bulimia nervosa, eating disorders not otherwise specified
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Nantes university Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Without eating disorders
With Eating disorders
Arm Description
Women consulting for infertility but without diagnosis of eating disorder.
Womenconsulting for infertility for which eating disorder is diagnosed.
Outcomes
Primary Outcome Measures
Children desire
Questionnaire scores of children desire (Fragebogen zum Kinderwunsch) , according to three dimensions:
Improved self-esteem''
Emotional Stabilization
Ambivalence
Secondary Outcome Measures
Dysmorphic
score Body Shape Questionnaire (BSQ)
Sexuality
History Questionnaire score Sexual (QHS)
Anxiety and depression
score on the Hospital Anxiety and Depression Scale (HAD)
Quality of life questionnaire
Quality of life questionnaire score FertiQol internationnal
Full Information
NCT ID
NCT02029365
First Posted
January 6, 2014
Last Updated
March 9, 2015
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02029365
Brief Title
Transversal, Controlled and Not Randomized Study, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women
Acronym
TCA2
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Eating Disorders
Keywords
Infertility, desire for children, eating disorder, anorexia nervosa, bulimia nervosa, eating disorders not otherwise specified
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Without eating disorders
Arm Type
Other
Arm Description
Women consulting for infertility but without diagnosis of eating disorder.
Arm Title
With Eating disorders
Arm Type
Other
Arm Description
Womenconsulting for infertility for which eating disorder is diagnosed.
Intervention Type
Other
Intervention Name(s)
Autoquestionnary
Intervention Description
autoquestionnary completed during the consultation for infertility
Intervention Type
Other
Intervention Name(s)
semi-structured interview
Intervention Description
phone interview
Primary Outcome Measure Information:
Title
Children desire
Description
Questionnaire scores of children desire (Fragebogen zum Kinderwunsch) , according to three dimensions:
Improved self-esteem''
Emotional Stabilization
Ambivalence
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Dysmorphic
Description
score Body Shape Questionnaire (BSQ)
Time Frame
30 days
Title
Sexuality
Description
History Questionnaire score Sexual (QHS)
Time Frame
30 days
Title
Anxiety and depression
Description
score on the Hospital Anxiety and Depression Scale (HAD)
Time Frame
30 days
Title
Quality of life questionnaire
Description
Quality of life questionnaire score FertiQol internationnal
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie GRALL-BRONNEC
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes university Hospital
City
Nantes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Transversal, Controlled and Not Randomized Study, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women
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