We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974649
First Posted: September 10, 2009
Last Update Posted: March 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Thomas D'Hooghe, University Hospital, Gasthuisberg
  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: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis

Resource links provided by NLM:


Further study details as provided by Thomas D'Hooghe, University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • psychological predictors of continuing or discontinuing infertility treatment [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 8, 2009
First Posted: September 10, 2009
Last Update Posted: March 29, 2013
Last Verified: March 2013

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

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