InfertilityNCT00974649
Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis
A study testing self-report questionnaire in people with Infertility, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- self-report questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- first IVF/ICSI treatment
- sufficient knowledge of Dutch to fill out questionnaires
- heterosexual couples
Who cannot join
- insufficient knowledge of Dutch
- having had previous IVF/ICSI treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Infertility
- Being tested
- self-report questionnaire
- Keywords
- drop-out, predictors of treatment continuation/discontinuation, IVF/ICSI, infertility, counseling, psychology, Assisted Reproduction, Counselling
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-report questionnaireBehavioural
validated self-report questionnaires on psychosocial determinants
| Study group | Role | What they receive |
|---|---|---|
| Included in questionnaire study | No intervention | Not described Receives: Behavioral: self-report questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological predictors of continuing or discontinuing infertility treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Principal investigator, Thomas D'Hooghe, University Hospital, Gasthuisberg
- Investigators
- Thomas D'Hooghe, M.D., PhD, Study director, University Hospital Gasthuisberg, Leuven, BelgiumUschi Van den Broeck, M.A., Principal investigator, University Hospitals Gasthuisberg, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974649
- Sponsor's protocol ID
- UZL FWO
- Status last verified
- Mar 2013
- First submitted
- 8 Sep 2009
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20338959
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis
- ClinicalTrials.gov ID
- NCT00974649
- Acronym / sponsor ID
- UZL FWO
- Conditions
- Infertility
- Keywords
- drop-out, predictors of treatment continuation/discontinuation, IVF/ICSI, infertility, counseling, psychology, Assisted Reproduction, Counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- Nov 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included in questionnaire study | No intervention | Behavioral: self-report questionnaire |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- first IVF/ICSI treatment
- sufficient knowledge of Dutch to fill out questionnaires
- heterosexual couples
Key exclusion criteria (2 listed)
- insufficient knowledge of Dutch
- having had previous IVF/ICSI treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-report questionnairevalidated self-report questionnaires on psychosocial determinants | Behavioural | Included in questionnaire study |
Primary outcome
psychological predictors of continuing or discontinuing infertility treatment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Results publication: PubMed 20338959Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas D'Hooghe, M.D., PhD study director
University Hospital Gasthuisberg, Leuven, Belgium
Uschi Van den Broeck, M.A. principal investigator
University Hospitals Gasthuisberg, Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-report questionnaire in people with Infertility, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological predictors of continuing or discontinuing infertility treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.