Psychosocial Determinants of Continuing or Discontinuing... | NCT00974649

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

NCT00974649

Sponsor

University Hospital, Gasthuisberg

Status

Completed

Last Update Posted

Mar 29, 2013Estimated

Enrollment

315Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

self-report questionnaire

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 8, 2009

First Submission Date that Met QC Criteria

Sep 9, 2009

First Posted Date

Sep 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2013

Last Update Posted Date

Mar 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas D'Hooghe, Professor, M.D., Phd, University Hospital, GasthuisbergPrincipal Investigator

Lead Sponsor

University Hospital, GasthuisbergOTHER

Collaborators

Name	Class
Fund for Scientific Research, Flanders, Belgium	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

315Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Included in questionnaire study	No Intervention		Behavioral: self-report questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
self-report questionnaire	Behavioral	validated self-report questionnaires on psychosocial determinants	Included in questionnaire study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
psychological predictors of continuing or discontinuing infertility treatment		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Gasthuisberg		Leuven	Leuven	3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20338959	Result	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases