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Transversal, Controlled and Not Randomized Study, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women (TCA2)

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ClinicalTrials.gov Identifier: NCT02029365
Recruitment Status : Terminated (recruitment difficulties)
First Posted : January 7, 2014
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Infertility Eating Disorders Other: Autoquestionnary Other: semi-structured interview Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Without eating disorders
Women consulting for infertility but without diagnosis of eating disorder.
Other: Autoquestionnary
autoquestionnary completed during the consultation for infertility

With Eating disorders
Womenconsulting for infertility for which eating disorder is diagnosed.
Other: Autoquestionnary
autoquestionnary completed during the consultation for infertility

Other: semi-structured interview
phone interview




Primary Outcome Measures :
  1. Children desire [ Time Frame: 30 days ]

    Questionnaire scores of children desire (Fragebogen zum Kinderwunsch) , according to three dimensions:

    • Improved self-esteem''
    • Emotional Stabilization
    • Ambivalence


Secondary Outcome Measures :
  1. Dysmorphic [ Time Frame: 30 days ]
    score Body Shape Questionnaire (BSQ)

  2. Sexuality [ Time Frame: 30 days ]
    History Questionnaire score Sexual (QHS)

  3. Anxiety and depression [ Time Frame: 30 days ]
    score on the Hospital Anxiety and Depression Scale (HAD)

  4. Quality of life questionnaire [ Time Frame: 30 days ]
    Quality of life questionnaire score FertiQol internationnal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029365


Locations
France
Nantes university Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Marie GRALL-BRONNEC Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02029365     History of Changes
Other Study ID Numbers: RC13_0449
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Keywords provided by Nantes University Hospital:
Infertility
desire for children
eating disorder
anorexia nervosa
bulimia nervosa
eating disorders not otherwise specified

Additional relevant MeSH terms:
Disease
Infertility
Feeding and Eating Disorders
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Mental Disorders