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

Infertility Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02029365
• Other study ID #: RC13_0449
• Status: Terminated
• Phase: N/A
• First received: January 6, 2014
• Last updated: March 9, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Disease
• Eating Disorders
• Infertility

Intervention

Other:
• Autoquestionnary
autoquestionnary completed during the consultation for infertility
• semi-structured interview
phone interview

Locations

Country	Name	City	State
France	Nantes university Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children desire	Questionnaire scores of children desire (Fragebogen zum Kinderwunsch) , according to three dimensions: Improved self-esteem''; Emotional Stabilization; Ambivalence	30 days	No
Secondary	Dysmorphic	score Body Shape Questionnaire (BSQ)	30 days	No
Secondary	Sexuality	History Questionnaire score Sexual (QHS)	30 days	No
Secondary	Anxiety and depression	score on the Hospital Anxiety and Depression Scale (HAD)	30 days	No
Secondary	Quality of life questionnaire	Quality of life questionnaire score FertiQol internationnal	30 days	No