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

October 29, 2026 updated by: Murdoch Childrens Research Institute

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 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 COM-B (Capability, Opportunity, Motivation - Behaviour) model.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Murdoch Children's Research Institute
        • Contact:
        • Sub-Investigator:
          • Debra Gook, PhD, Senior Investigator
        • Sub-Investigator:
          • Margaret Zacharin, MBBS, FRACP, PhD
        • Sub-Investigator:
          • Michael Assis, PhD, Postdoc Research Fellow
        • Sub-Investigator:
          • Hossam Elzeiny, MB ChB, AMC Certificate, FRANZ
        • Sub-Investigator:
          • Zobaida Edib, PhD, Postdoc Research Fellow
        • Sub-Investigator:
          • Apoorva Bhargava, MPH, Research Fellow
        • Sub-Investigator:
          • Diana Navarro - Perez, PhD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
105 males aged 18 years and above who had testicular tissue cryopreservation at the RCH
Other: No intervention

No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
Baseline
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.
Baseline
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)
Baseline
Perceived behavioural control as measured by responses to the Theory of Planned Behaviour questionnaire.
Time Frame: Baseline

Responses to either disagree or agree.
Baseline
Unmet fertility information needs as measured by The Unmet Needs Survey (as used/adapted from Benedicts et al., 2023).
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.
Baseline
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.
Baseline
Cancer impact and information as measured by The Cancer Impact and Information Needs survey (as used by the AYA HOPE Study Collaborative Group - Harlan et al., 2011).
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).
Baseline
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.
Baseline
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.
Baseline
Depression as measured by 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.
Baseline
Stress as measured by 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.
Baseline
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 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.
Baseline
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.
Baseline
Reproductive Goals (as adapted from Lehmann et al., 2017).
Time Frame: Baseline

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Murdoch Childrens Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Melbourne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yasmin Jayasinghe, MBBS, FRANZCOG, PhD, University of Melbourne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREC 130619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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), participant information and consent form (PICF).

IPD Sharing Time Frame

Following analysis and article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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