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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974649
• Other study ID #: UZL FWO
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: March 28, 2013
• Start date: November 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2013
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infertility

Intervention

Behavioral:
• self-report questionnaire
validated self-report questionnaires on psychosocial determinants

Locations

Country	Name	City	State
Belgium	University Hospitals Gasthuisberg	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg	Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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/deq — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychological predictors of continuing or discontinuing infertility treatment		2 years	No