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Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue

Fertility · Testicular Tissue Cryopreserved · Fertility Preservation

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - Not specified
Sex eligible
Male
Healthy volunteers
Not accepted
Participants
105 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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)

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Assigned male at birth who have completed oncology treatment of childhood oncology treatment (they may have had malignant or benign disease)
  • Who are 18 years and over
  • Who had testicular tissue cryopreservation as part of their childhood oncology care
  • Who have completed curative gonadotoxic treatment.
  • Can communicate in English.
  • Can provide a signed written informed consent

Exclusion Criteria:

  • Deceased patients
  • Patients currently undergoing active gonadotoxic cancer treatment.
  • Patients who are palliative

Study population

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.

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Treatment, groups and participation

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Assignment
Not reported
Masking
Not reported
105 males aged 18 years and above who had testicular tissue cryopreservation at RCH

Not reported in this registry record.

Other: No intervention

No intervention OTHER

No intervention

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Willingness to consider testicular tissue grafting as measured by responses to a likert scale on the study survey

Time frame: Baseline

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.

Secondary measures

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

Time frame: Baseline

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.

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

Time frame: Baseline

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.

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

Time frame: Baseline

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.

Willingness to consider testicular tissue grafting according to perceived potential beneficial outcomes as measured by responses to a likert scale on the study survey

Time frame: Baseline

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.

Willingness to consider testicular tissue grafting according to perceived safety as measured by responses to a likert scale on the study survey

Time frame: Baseline

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.

Perceived social pressure from partners, parents, general practitioners (GP) and religious leaders as measured by responses to the Theory of Planned Behaviour questionnaire.

Time frame: Baseline

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)

Perceived behavioural control as measured by responses to the Theory of Planned Behaviour questionnaire.

Time frame: Baseline

Responses to either disagree or agree.

Unmet fertility information needs as measured by The Unmet Needs Survey (per Benedict)

Time frame: Baseline

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.

Decisional Conflict as measured by the Decisional Conflict Scale (DCS)

Time frame: Baseline

The decisional conflict scale ranges between 0 to 100.Higher scores on the scale indicate greater decisional conflict.

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)]

Time frame: Baseline

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).

Financial toxicity survey as measured by the Comprehensive Score for Financial Toxicity (COST).

Time frame: Baseline

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.

Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 6a

Time frame: Baseline

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.

Depression as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) 6a

Time frame: Baseline

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.

Stress as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) 8a

Time frame: Baseline

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.

Optimism as measured by the adapted Life Orientation Scale

Time frame: Baseline

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.

Medical Decision-Making preferences as measured by the Control Preferences Scale

Time frame: Baseline

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.

Reproductive Goals (per Lehmann [adapted])

Time frame: Baseline

Reproductive goals are assessed using 5 items categorising responses between yes, no or unsure.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

Murdoch Children's Research InstituteParkville, Victoria, AustraliaStatus unknown
Diana Navarro -Perez, PhDCONTACTd.navarroperez@unimelb.edu.au03 8345 3721
Debra Gook, PhD, Senior InvestigatorSUB_INVESTIGATOR
Margaret Zacharin, MBBS, FRACP, PhDSUB_INVESTIGATOR
Michael Assis, PhD, Postdoc Research FellowSUB_INVESTIGATOR
Hossam Elzeiny, MB ChB, AMC Certificate, FRANZSUB_INVESTIGATOR
Zobaida Edib, PhD, Postdoc Research FellowSUB_INVESTIGATOR
Apoorva Bhargava, MPH, Research FellowSUB_INVESTIGATOR
Diana Navarro - Perez, PhD, MScSUB_INVESTIGATOR
View location on map ↗

Study team and timeline

Lead sponsor
Murdoch Childrens Research Institute
Study start
Dec 1, 2026 Estimated
Primary completion
Dec 31, 2027 Estimated
Study completion
Jun 30, 2028 Estimated
First posted
Nov 4, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Diana Navarro - Perez, PhDCONTACTd.navarroperez@unimelb.edu.au03 8345 3721
Official study title

Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue (PACTT)

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Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026