InfertilityNCT02411214
Decisional Process in Male Fertility Preservation
An observational study of Infertility and Quality of Life, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
The survey analyses how to improve the decision-making process for fertility preservation in the pediatric population based on 1. patient and parent feelings about fertility preservation counselling 2. influence of the emotional state of patients and parents on fertility preservation acceptance 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility, Quality of Life, Cancer
- What is being tested?
- survey
- How many people
- 348 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013 and their parents
Who may be able to join
- prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013
Who cannot join
- none
About this study
Official title: Fertility Preservation in the Male Pediatric Population: a Patient and Parent Perspective of Factors Influencing the Decisional Process
The survey analyses how to improve the decision-making process for fertility preservation in the pediatric population based on
- patient and parent feelings about fertility preservation counselling
- influence of the emotional state of patients and parents on fertility preservation acceptance
- support of medical staff and family The study revealed that attention to the fertility preservation pathways was important for the satisfaction of patient's and parent's expectations
Read the detailed description
Questionnaire survey via regular mail to an eligible population (boys and adolescents aged 0 to 18 years diagnosed with cancer at the Cliniques universitaires Saint Luc) between January 2005 and May 2013.
Three different questionnaires, for children (<12 years and 12-18 years) and parents respectively, established based on information from focus groups and subsequently reviewed by the institutional ethics board before being sent.
- Conditions
- Infertility, Quality of Life, Cancer
- Being tested
- survey
- Medical subject headings
- Infertility, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
questionnaire survey sent by regular mail for 3 groups
| Study group | Role | What they receive |
|---|---|---|
| <12 years | children under 12 years diagnosed with cancer questionnaire survey Receives: Other: survey | |
| 12-18 years | adolescents diagnosed with cancer questionnaire survey Receives: Other: survey | |
| parents | parents of children and adolescents diagnosed with cancer questionnaire survey Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
factors improving the decision-making process for fertility preservation
factors improving the decision-making process for fertility preservation assessed by three specific questionnaires (parent, adolescent and children)
Measured: less than 1 year
Secondary outcomes (3)
patient and parent feelings about fertility counseling
patient and parent feelings about fertility counseling assessed by three specific questionnaires (parent, adolescent and children)
Measured: less than 1 year
influence of the emotional state of parents and patients on fertility preservation acceptance
influence of the emotional state of parents and patients on fertility preservation acceptance assessed by three specific questionnaires (parent, adolescent and children)
Measured: less than 1 year
support of medical staff and family
support of medical staff and family assessed by three specific questionnaires support of medical staff and family (parent, adolescent and children)
Measured: less than 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
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.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wyns, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411214
- Sponsor's protocol ID
- FP1
- Status last verified
- Apr 2015
- First submitted
- 2 Apr 2015
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wyns C, Collienne C, Shenfield F, Robert A, Laurent P, Roegiers L, Brichard B. Fertility preservation in the male pediatric population: factors influencing the decision of parents and children. Hum Reprod. 2015 Sep;30(9):2022-30. doi: 10.1093/humrep/dev161. Epub 2015 Jul 3.
PubMed 26141713
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation in the Male Pediatric Population: a Patient and Parent Perspective of Factors Influencing the Decisional Process
- ClinicalTrials.gov ID
- NCT02411214
- Acronym / sponsor ID
- FP1
- Conditions
- Infertility, Quality of Life, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Apr 2015 (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 survey analyses how to improve the decision-making process for fertility preservation in the pediatric population based on
- patient and parent feelings about fertility preservation counselling
- influence of the emotional state of patients and parents on fertility preservation acceptance
- support of medical staff and family The study revealed that attention to the fertility preservation pathways was important for the satisfaction of patient's and parent's expectations
Detailed description
Questionnaire survey via regular mail to an eligible population (boys and adolescents aged 0 to 18 years diagnosed with cancer at the Cliniques universitaires Saint Luc) between January 2005 and May 2013.
Three different questionnaires, for children (<12 years and 12-18 years) and parents respectively, established based on information from focus groups and subsequently reviewed by the institutional ethics board before being sent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| <12 years | – | Other: surveychildren under 12 years diagnosed with cancer questionnaire survey |
| 12-18 years | – | Other: surveyadolescents diagnosed with cancer questionnaire survey |
| parents | – | Other: surveyparents of children and adolescents diagnosed with cancer questionnaire survey |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013 and their parents
Key inclusion criteria (1 listed)
- prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| surveyquestionnaire survey sent by regular mail for 3 groups | Other | 12-18 years, <12 years, parents |
Primary outcome
factors improving the decision-making process for fertility preservation
Time frame: less than 1 year
factors improving the decision-making process for fertility preservation assessed by three specific questionnaires (parent, adolescent and children)
3 secondary outcomes
patient and parent feelings about fertility counseling
Time frame: less than 1 year
influence of the emotional state of parents and patients on fertility preservation acceptance
Time frame: less than 1 year
support of medical staff and family
Time frame: less than 1 year
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 8 Apr 2015.
- Derived from this study: PubMed 26141713Wyns C, Collienne C, Shenfield F, Robert A, Laurent P, Roegiers L, Brichard B. Fertility preservation in the male pediatric population: factors influencing the decision of parents and children. Hum Reprod. 2015 Sep;30(9):2022-30. doi: 10.1093/humrep/dev161. Epub 2015 Jul 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Quality of Life, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 1 inclusion and 1 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
factors improving the decision-making process for fertility preservation (time frame: less than 1 year). 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 NCT02411214, 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 8 Apr 2015.