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Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
self-report questionnaire
Sponsored by
University Hospital, Gasthuisberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring drop-out, predictors of treatment continuation/discontinuation, IVF/ICSI, infertility, counseling, psychology, Assisted Reproduction, Counselling

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • first IVF/ICSI treatment
  • sufficient knowledge of Dutch to fill out questionnaires
  • heterosexual couples

Exclusion Criteria:

  • insufficient knowledge of Dutch
  • having had previous IVF/ICSI treatment

Sites / Locations

  • University Hospitals Gasthuisberg

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Included in questionnaire study

Arm Description

Outcomes

Primary Outcome Measures

psychological predictors of continuing or discontinuing infertility treatment

Secondary Outcome Measures

Full Information

First Posted
September 8, 2009
Last Updated
March 28, 2013
Sponsor
University Hospital, Gasthuisberg
Collaborators
Fund for Scientific Research, Flanders, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT00974649
Brief Title
Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis
Official Title
Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gasthuisberg
Collaborators
Fund for Scientific Research, Flanders, Belgium

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study aims to explore and analyse the decision making process of couples in regards to continuing or discontinuing infertility treatment. A longitudinal, prospective cohort design is used which allows the monitoring of patients over a longer period of time. Data will be collected quantitatively (questionnaires) as well as qualitatively (in-depth interviews) to allow for a more specific and in depth experience than can be obtained by using a questionnaire study. Innovative aspects of the study include: exploration of determinants of continuing and discontinuing infertility treatment by using a comprehensive psychological theory (both surface and in-depth) exploration of gender differences in the decision making process in continuing or discontinuing treatment longitudinal and prospective arm of the study will allow to gain insight into the 'process' prediction of continuing/discontinuing treatment based on psychological variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
drop-out, predictors of treatment continuation/discontinuation, IVF/ICSI, infertility, counseling, psychology, Assisted Reproduction, Counselling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Included in questionnaire study
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
self-report questionnaire
Intervention Description
validated self-report questionnaires on psychosocial determinants
Primary Outcome Measure Information:
Title
psychological predictors of continuing or discontinuing infertility treatment
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: first IVF/ICSI treatment sufficient knowledge of Dutch to fill out questionnaires heterosexual couples Exclusion Criteria: insufficient knowledge of Dutch having had previous IVF/ICSI treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas D'Hooghe, M.D., PhD
Organizational Affiliation
University Hospital Gasthuisberg, Leuven, Belgium
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Uschi Van den Broeck, M.A.
Organizational Affiliation
University Hospitals Gasthuisberg, Leuven, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
20338959
Citation
Van den Broeck U, D'Hooghe T, Enzlin P, Demyttenaere K. Predictors of psychological distress in patients starting IVF treatment: infertility-specific versus general psychological characteristics. Hum Reprod. 2010 Jun;25(6):1471-80. doi: 10.1093/humrep/deq030. Epub 2010 Mar 25.
Results Reference
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Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis

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