Satisfaction SurveyQUALIFERTNCT07140549
Survey of Patients Who Received Fertility Preservation Counseling and Underwent Testicular Tissue Cryopreservation Prior to Gonadotoxic Treatment During Childhood or Peripuberty
A study testing Survey using a questionnaire. in people with Satisfaction Survey and Fertility Perservation, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Chemotherapy and radiotherapy can lead to spermatogonial stem cell depletion in pre- and peripubertal boys, potentially resulting in infertility during adulthood A testicular biopsy is considered a safe procedure performed in children prior to gonadotoxic treatment as part of a fertility preservation strategy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Satisfaction Survey, Fertility Perservation
- What is being tested?
- Survey using a questionnaire.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who have participated in the fertility preservation program aged 18 years old and above
Who cannot join
- Deceased patients. Patients undergoing treatment for disease relapse. Patients suffering from a documented mental disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Survey of Patients Who Underwent Testicular Tissue Cryopreservation for Fertility Preservation Prior to Gonadotoxic Therapy in Childhood or Peripuberty
Chemotherapy and radiotherapy can lead to spermatogonial stem cell depletion in pre- and peripubertal boys, potentially resulting in infertility during adulthood A testicular biopsy is considered a safe procedure performed in children prior to gonadotoxic treatment as part of a fertility preservation strategy. At the time of the procedure, parental involvement is essential-both in their role as legal guardians and due to the limited cognitive capacity of young boys to fully comprehend fertility preservation counseling.
Long-term follow-up is necessary to evaluate the impact on fertility outcomes, psychological well-being, and overall satisfaction. The aim of this survey is to assess the perceived impact of fertility preservation counseling and the physical and emotional effects of undergoing testicular biopsy in this population, with the goal of identifying opportunities to improve patient experience and clinical care for future patients.
- Conditions
- Satisfaction Survey, Fertility Perservation
- Being tested
- Survey using a questionnaire.
- Keywords
- fertility preservation, boys, gonadotoxic treatment, male infertility, testicular tissue biopsy, spermatogonial stem cell, cryopreservation, long-term follow-up, survey
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
A monocentric experimental study conducted as a survey, including patients enrolled in our fertility preservation program between May 2005 and May 2020.
Participants were asked about their current reproductive health status, their experience with the fertility preservation process, and their overall satisfaction with the care they received.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent gonadotoxic treatment for oncological or benign disease | Experimental | This survey study aims to assess the long-term outcomes and patient satisfaction of men who underwent a fertility preservation procedure i.e., a testicular biopsy with cryopreservation of immature testicular tissue, during prepuberty or peripuberty at the Cliniques Universitaires Saint Luc (CUSL) since the start of the fertility preservation program in 2005. Participants will be asked about their current reproductive health status, their experience with the fertility preservation process, and their overall satisfaction with the care they received. Receives: Other: Survey using a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact on quality of life of fertility preservation during childhood or adolescence.
Assessment will be conducted by means of a confidential survey in > 18 yo patients who have undergone in their childhood a fertility preservation.
The number of patients who are eligible for the follow-up survey (n = 64) within the fertility preservation program of the CUSL is important compared to the overall number of boys who have participated in such a FP programme worldwide (n=1033) in 2023.
Recipients' satisfaction level will be evaluated by both general and specific scores. The general satisfaction score is calculated by combining the responses to questions rating specifically recipients' satisfaction on specific items using a 5 elements Likert scale (Very Dissatisfied to Very Satisfied) and responses to closed questions which inquire participants' global satisfaction on specific subjects.
Measured: From the start of the program in may 2005 and the last patient enrolled in may 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Jul 2025
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction SurveyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Wyns, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140549
- Sponsor's protocol ID
- 2023/14JUI/263
- Acronym
- QUALIFERT
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Patients Who Underwent Testicular Tissue Cryopreservation for Fertility Preservation Prior to Gonadotoxic Therapy in Childhood or Peripuberty
- ClinicalTrials.gov ID
- NCT07140549
- Acronym / sponsor ID
- QUALIFERT / 2023/14JUI/263
- Conditions
- Satisfaction Survey, Fertility Perservation
- Keywords
- fertility preservation, boys, gonadotoxic treatment, male infertility, testicular tissue biopsy, spermatogonial stem cell, cryopreservation, long-term follow-up
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 24 Aug 2025 (actual)
- 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.
Chemotherapy and radiotherapy can lead to spermatogonial stem cell depletion in pre- and peripubertal boys, potentially resulting in infertility during adulthood A testicular biopsy is considered a safe procedure performed in children prior to gonadotoxic treatment as part of a fertility preservation strategy. At the time of the procedure, parental involvement is essential-both in their role as legal guardians and due to the limited cognitive capacity of young boys to fully comprehend fertility preservation counseling.
Long-term follow-up is necessary to evaluate the impact on fertility outcomes, psychological well-being, and overall satisfaction. The aim of this survey is to assess the perceived impact of fertility preservation counseling and the physical and emotional effects of undergoing testicular biopsy in this population, with the goal of identifying opportunities to improve patient experience and clinical care for future patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent gonadotoxic treatment for oncological or benign disease | Experimental | Other: Survey using a questionnaire.This survey study aims to assess the long-term outcomes and patient satisfaction of men who underwent a fertility preservation procedure i.e., a testicular biopsy with cryopreservation of immature testicular tissue, during prepuberty or peripuberty at the Cliniques Universitaires Saint Luc (CUSL) since the start of the fertility preservation program in 2005. Participants will be asked about their current reproductive health status, their experience with the fertility preservation process, and their overall satisfaction with the care they received. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who have participated in the fertility preservation program aged 18 years old and above
Key exclusion criteria (1 listed)
- Deceased patients. Patients undergoing treatment for disease relapse. Patients suffering from a documented mental disorder.
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 |
|---|---|---|
| Survey using a questionnaire.A monocentric experimental study conducted as a survey, including patients enrolled in our fertility preservation program between May 2005 and May 2020. Participants were asked about their current reproductive health status, their experience with the fertility preservation process, and their overall satisfaction with the care they received. | Other | Patients who underwent gonadotoxic treatment for oncological or benign disease |
Primary outcome
The impact on quality of life of fertility preservation during childhood or adolescence.
Time frame: From the start of the program in may 2005 and the last patient enrolled in may 2020
Assessment will be conducted by means of a confidential survey in > 18 yo patients who have undergone in their childhood a fertility preservation. The number of patients who are eligible for the follow-up survey (n = 64) within the fertility preservation program of the CUSL is important compared to the overall number of boys who have participated in such a FP programme worldwide (n=1033) in 2023. Recipients' satisfaction level will be evaluated by both general and specific scores. The general satisfaction score is calculated by combining the responses to questions rating specifically recipients' satisfaction on specific items using a 5 elements Likert scale (Very Dissatisfied to Very Satisfied) and responses to closed questions which inquire participants' global satisfaction on specific subjects.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Christine Wyns, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey using a questionnaire. in people with Satisfaction Survey and Fertility Perservation, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 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: enrolling by invitation, as of the sponsor's last update on 24 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
The impact on quality of life of fertility preservation during childhood or adolescence. (time frame: From the start of the program in may 2005 and the last patient enrolled in may 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.