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

This study has been completed.
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Thomas D'Hooghe, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00974649
First received: September 8, 2009
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

  1. exploration of determinants of continuing and discontinuing infertility treatment by using a comprehensive psychological theory (both surface and in-depth)
  2. exploration of gender differences in the decision making process in continuing or discontinuing treatment
  3. longitudinal and prospective arm of the study will allow to gain insight into the 'process'
  4. prediction of continuing/discontinuing treatment based on psychological variables.

Condition Intervention
Infertility
 Behavioral: self-report questionnaire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • psychological predictors of continuing or discontinuing infertility treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 315
Study Start Date: November 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Included in questionnaire study Behavioral: self-report questionnaire
validated self-report questionnaires on psychosocial determinants

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974649

Locations
Belgium
University Hospitals Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Fund for Scientific Research, Flanders, Belgium
Investigators
Study Director: Thomas D'Hooghe, M.D., PhD University Hospital Gasthuisberg, Leuven, Belgium
Principal Investigator: Uschi Van den Broeck, M.A. University Hospitals Gasthuisberg, Leuven, Belgium
  More Information

Publications:

Responsible Party: Thomas D'Hooghe, Professor, M.D., Phd, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00974649     History of Changes
Other Study ID Numbers: UZL FWO
Study First Received: September 8, 2009
Last Updated: March 28, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
drop-out
predictors of treatment continuation/discontinuation
IVF/ICSI
infertility
counseling
 psychology
Assisted Reproduction
Counselling
Psychology

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013