NCT00974649

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

3.6 years

First QC Date

September 8, 2009

Last Update Submit

March 28, 2013

Conditions

Infertility

Keywords

drop-outpredictors of treatment continuation/discontinuationIVF/ICSIinfertilitycounselingpsychologyAssisted ReproductionCounselling

Outcome Measures

Primary Outcomes (1)

  • psychological predictors of continuing or discontinuing infertility treatment

    2 years

Study Arms (1)

Included in questionnaire study

NO INTERVENTION
Behavioral: self-report questionnaire

Interventions

self-report questionnaireBEHAVIORAL

validated self-report questionnaires on psychosocial determinants

Included in questionnaire study

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Gasthuisberg

Leuven, Leuven, 3000, Belgium

Location

Related 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/deq030. Epub 2010 Mar 25.

    PMID: 20338959RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Thomas D'Hooghe, M.D., PhD

    University Hospital Gasthuisberg, Leuven, Belgium

    STUDY DIRECTOR

  • Uschi Van den Broeck, M.A.

    University Hospitals Gasthuisberg, Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, M.D., Phd

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 10, 2009

Study Start

November 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

BE(1)