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

NCT ID: NCT00974649

Last Updated: 2013-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2011-06-30

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:

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.

Conditions

Infertility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Included in questionnaire study

Group Type: NO_INTERVENTION

self-report questionnaire

Intervention Type: BEHAVIORAL

validated self-report questionnaires on psychosocial determinants

Interventions

self-report questionnaire

validated self-report questionnaires on psychosocial determinants

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role: collaborator

University Hospital, Gasthuisberg

OTHER

Sponsor Role: lead

Responsible Party

Thomas D'Hooghe

Professor, M.D., Phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas D'Hooghe, M.D., PhD

Role: STUDY_DIRECTOR

University Hospital Gasthuisberg, Leuven, Belgium

Uschi Van den Broeck, M.A.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Gasthuisberg, Leuven, Belgium

Locations

University Hospitals Gasthuisberg

Leuven, Leuven, Belgium

Countries

Belgium

References

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.

Reference Type: RESULT

PMID: 20338959 (View on PubMed)

Other Identifiers

UZL FWO

Identifier Type: -

Identifier Source: org_study_id