An observational study in Fertility, Testicular Tissue Cryopreserved and Fertility Preservation, sponsored by Murdoch Childrens Research Institute. Not yet recruiting at 1 site in Australia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Murdoch Childrens Research Institute · Observational
Cancer treatment can cause infertility. Fertility preservation is possible for many populations through, egg, sperm or ovarian tissue freezing prior to cancer treatment. However, there is no established technology to protect the fertility of pre-pubertal boys.
Outcomes: Primary outcome is to identify whether male (assigned male at birth) oncology survivors who had prior testicular tissue cryopreservation would be willing to undergo testicular tissue grafting. The secondary outcomes identify what factors influence decision for testicular grafting including demographics factors, fertility related knowledge, reproductive goals and concerns, unmet fertility needs, decisional conflict and regret about fertility care, patient reported outcome measures (stress and anxiety), attempted or actual parenthood or natural fertility restoration
Participants: 105 Male aged 18 years and over who completed oncology treatment at the Royal Children's Hospital (RCH) at least one year prior and had testicular tissue cryopreservation for fertility preservation.
Sites: Murdoch Children Research Institute (MCRI)
Cancer treatment can cause infertility. Fertility preservation is possible for many populations through egg, sperm or ovarian tissue freezing prior to cancer treatment. There is no established technology to protect the fertility of prepubertal boys. Many centres internationally, including the Royal Children's Hospital, have offered freezing of testis tissue as a new technology, in the hope that technology will develop to be able to mature the tissue into sperm so that it can be used for parenthood. In animals, grafting of the testis tissue back into the body has resulted in successful births. This has paved the way for testicular tissue grafting in humans as a novel technology. The primary aim of this study is to identify whether male (assigned male at birth) patients who have completed oncology treatment who had prior testicular tissue cryopreservation would be willing to undergo testicular tissue grafting. Predictive factors and barriers will also be assessed. We will ask participants to complete a survey which will take 15 minutes. Participants will be reimbursed for their time. They will be referred to reproductive counsellors if participation causes emotional discomfort or distress
Study Question: What are the factors influencing intention to autograft previously stored cryopreserved testicular tissue for the purposes of fertility restoration?
Study Objectives: To identify barriers, enablers and facilitators for testicular tissue grafting in adult who have completed oncology treatment who had previously undergone testicular tissue cryopreservation in childhood.
Primary Objective: To identify whether patients who have completed oncology treatment who had testicular tissue cryopreservation would be willing to undergo testicular tissue grafting.
Secondary Objective: to identify what factors influence decisions for testicular tissue grafting including demographic factors, fertility-related knowledge, reproductive goals and concerns, unmet fertility needs, decisional conflict patient reported outcome measures (stress and anxiety), attempted or actual parenthood or natural fertility restoration.
Design: Cross-sectional survey of patients who have completed oncology treatment who had prior testicular tissue cryopreservation at The Royal Children's Hospital (RCH) as part of their oncology treatment. Validated and purposively designed surveys (by clinician scientists) and utilised in previous studies of Adolescent and Young Adult (AYA) Oncofertility will identify barriers and enablers. Qualitative data will be grouped according to The Theory of Planned Behaviour and the Capability, Opportunity, Motivation - Behaviour (COM-B) model.
Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants are identified from the Melbourne Oncofertility Registry (MORE Registry) as patients who had testicular tissue cryopreservation at the Royal Children's Hospital as part of their cancer treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: No intervention
No intervention
Willingness to consider testicular tissue grafting as measured by responses to a likert scale on the study survey
Willingness to undergo testicular tissue grafting as measured by the likert scale will range from 1 (strongly agree) to 7 (strongly disagree). Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.
Time frame: Baseline
Willingness to consider testicular tissue grafting within a specified time period (1 year) as measured by responses to a likert scale on the study survey
Willingness to undergo testicular tissue grafting as measured by the likert scale will range from 1 (strongly agree) to 7 (strongly disagree). Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.
Time frame: Baseline
Willingness to consider testicular tissue grafting within a specified time period (5 year) as measured by responses to a likert scale on the study survey
Willingness to undergo testicular tissue grafting as measured by the likert scale will range from 1 (strongly agree) to 7 (strongly disagree). Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.
Time frame: Baseline
Willingness to consider testicular tissue grafting within a specified time period (10 year) as measured by responses to a likert scale on the study survey
Willingness to undergo testicular tissue grafting as measured by the likert scale will range from 1 (strongly agree) to 7 (strongly disagree). Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.
Time frame: Baseline
Willingness to consider testicular tissue grafting according to perceived potential beneficial outcomes as measured by responses to a likert scale on the study survey
Willingness to undergo testicular tissue grafting in the hope that it will contribute to \[parenthood as soon as possible\] \[mature sperm that can be frozen\] \[improved guidelines for testicular grafting\]. Responses from 1 strongly agree to 7 strongly disagree. Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.
Time frame: Baseline
Willingness to consider testicular tissue grafting according to perceived safety as measured by responses to a likert scale on the study survey
Willingness to undergo testicular tissue grafting because it is \[safe\] \[acceptable\] \[within my right to do so\] responses as percentages 0, 1, 5, 10, 20% or more. Responses from 1 strongly agree to 7 strongly disagree. Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.
Time frame: Baseline
Perceived social pressure from partners, parents, general practitioners (GP) and religious leaders as measured by responses to the Theory of Planned Behaviour questionnaire.
Responses from 1 strongly agree to 7 strongly disagree. Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing)
Time frame: Baseline
Perceived behavioural control as measured by responses to the Theory of Planned Behaviour questionnaire.
Responses to either disagree or agree.
Time frame: Baseline
Unmet fertility information needs as measured by The Unmet Needs Survey (per Benedict)
Unmet fertility information needs is assessed on a 6-point scale, ranging from 0 to 5, higher scores indicate greater unmet information needs. Unmet fertility information needs will be summarised as a mean score.
Time frame: Baseline
Decisional Conflict as measured by the Decisional Conflict Scale (DCS)
The decisional conflict scale ranges between 0 to 100.Higher scores on the scale indicate greater decisional conflict.
Time frame: Baseline
Cancer impact and information as measured by The Cancer Impact and Information Needs survey [per Adolescent and Young Adult Health Outcomes and Patient Experience (AYA HOPE)]
Assess opportunity of making a decision measured by cancer impact and information needs. Cancer impact and information needs are assessed on a 6 point Likert scale (1 = Very negative impact and 6 = Does not apply).
Time frame: Baseline
Financial toxicity survey as measured by the Comprehensive Score for Financial Toxicity (COST).
Financial toxicity scale is evaluated using an 11 items survey where scores range from 0 to 44 with lower scores indicating a higher cancer-related financial impact.
Time frame: Baseline
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 6a
PROMIS anxiety is assessed using their short form with 6 items (PROMIS 6a) items in a 5 Likert scale (1 = never and 5 = always) raw scores are transformed using PROMIS T-score tables, higher T score means worse health.
Time frame: Baseline
Depression as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) 6a
PROMIS depression is assessed using their short form with 6 items (PROMIS 6a) items in a 5 Likert scale (1 = never and 5 = always) raw scores are transformed using PROMIS T-score tables, higher T score means worse health.
Time frame: Baseline
Stress as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) 8a
PROMIS stress is assessed using its short form (PROMIS 8a) 8 items in a 5 Likert scale (1 = never and 5 = always) raw scores are transformed using PROMIS T-score tables, higher T score means worse health.
Time frame: Baseline
Optimism as measured by the adapted Life Orientation Scale
Optimism (Life Orientation) scale is used in the reduced form with only the optimistic measures (3-item Life Orientation Test-Revised (LOT-R) optimism subscale) with responses assessed in a 5-point Likert scale ranging from 1 = strongly disagree and 5 = strongly agree, higher scores indicate higher dispositional optimism.
Time frame: Baseline
Medical Decision-Making preferences as measured by the Control Preferences Scale
Medical Decision-Making preference is evaluated following the Control Preference Scale, where 5 items are ranked from the most preferred to the least preferred option, the highest rank item will determine if the chosen role is active, passive or collaborative.
Time frame: Baseline
Reproductive Goals (per Lehmann [adapted])
Reproductive goals are assessed using 5 items categorising responses between yes, no or unsure.
Time frame: Baseline
Plan to share: Yes — De- identified individual participant data (IPD) will be shared with study collaborators upon request and as necessary to facilitate research collaborations and study publications. Individual participant data that underlie the results reported after de-identification (text, tables, figures and appendices).
Supporting information: Informed consent form
Time frame: Following analysis and article publication.
Access criteria: Only authorised study site staff will have access to de-identified information. De-identified IPD will be shared with collaborators only in specific circumstances where sharing the data will benefits and extend research collaborations.
Data sharing details ↗ · www.mcri.edu.au
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Murdoch Childrens Research Institute