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

March 9, 2015 updated by: Nantes University Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children desire
Time Frame: 30 days

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysmorphic
Time Frame: 30 days
score Body Shape Questionnaire (BSQ)
30 days
Sexuality
Time Frame: 30 days
History Questionnaire score Sexual (QHS)
30 days
Anxiety and depression
Time Frame: 30 days
score on the Hospital Anxiety and Depression Scale (HAD)
30 days
Quality of life questionnaire
Time Frame: 30 days
Quality of life questionnaire score FertiQol internationnal
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Marie GRALL-BRONNEC, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC13_0449

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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