Trial record 3 of 92 for:    Open Studies | "Eating Disorders"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02029365
First received: January 6, 2014
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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 Intervention
Infertility
Eating Disorders
Other: Autoquestionnary
Other: semi-structured interview

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Children desire [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

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


Secondary Outcome Measures:
  • Dysmorphic [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    score Body Shape Questionnaire (BSQ)

  • Sexuality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    History Questionnaire score Sexual (QHS)

  • Anxiety and depression [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    score on the Hospital Anxiety and Depression Scale (HAD)

  • Quality of life questionnaire [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Quality of life questionnaire score FertiQol internationnal


Estimated Enrollment: 203
Study Start Date: January 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029365

Contacts
Contact: Mélanie BRUNEAU mel.ambre@gmail.com
Contact: Marie GRALL-BRONNEC marie.bronnec@chu-nantes.fr

Locations
France
Nantes university Hospital Recruiting
Nantes, France
Contact: Mélanie BRUNEAU       mel.ambre@gmail.com   
Contact: Marie GRALL-BRONNEC       marie.bronnec@chu-nantes.fr   
Principal Investigator: Marie GRALL-BRONNEC         
Sub-Investigator: Paul BARRIERE         
Sub-Investigator: Agnès COLOMBEL         
Sub-Investigator: Sophie MIRAILLIE         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Marie GRALL-BRONNEC Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02029365     History of Changes
Other Study ID Numbers: RC13_0449
Study First Received: January 6, 2014
Last Updated: May 26, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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:
Eating Disorders
Infertility
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female
Salicylic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 19, 2014