NCT02029365

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

January 6, 2014

Last Update Submit

March 9, 2015

Conditions

InfertilityEating Disorders

Keywords

Infertilitydesire for childreneating disorderanorexia nervosabulimia nervosaeating disorders not otherwise specified

Outcome Measures

Primary Outcomes (1)

  • Children desire

    Questionnaire scores of children desire (Fragebogen zum Kinderwunsch) , according to three dimensions: * Improved self-esteem'' * Emotional Stabilization * Ambivalence

    30 days

Secondary Outcomes (4)

  • Dysmorphic

    30 days

  • Sexuality

    30 days

  • Anxiety and depression

    30 days

  • Quality of life questionnaire

    30 days

Study Arms (2)

Without eating disorders

OTHER

Women consulting for infertility but without diagnosis of eating disorder.

Other: Autoquestionnary

With Eating disorders

OTHER

Womenconsulting for infertility for which eating disorder is diagnosed.

Other: AutoquestionnaryOther: semi-structured interview

Interventions

AutoquestionnaryOTHER

autoquestionnary completed during the consultation for infertility

With Eating disordersWithout eating disorders
semi-structured interviewOTHER

phone interview

With Eating disorders

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes university Hospital

Nantes, France

Location

MeSH Terms

Conditions

InfertilityFeeding and Eating DisordersAnorexia NervosaBulimia Nervosa

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Marie GRALL-BRONNEC

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 7, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

FR(1)