AzTrials
AzTrials

FertilityPACTTNCT07915375

Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue

An observational study of Fertility and Testicular Tissue Cryopreserved, run by Murdoch Childrens Research Institute at 1 site in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
How many people
105 participants
Where
1 siteAustralia
Study dates
1 Dec 2026to 30 Jun 2028
Phase
Observational
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

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Diana Navarro - Perez, PhD contact

03 8345 3721

d.navarroperez@unimelb.edu.au

Australia1 site
  • Murdoch Children's Research Institute

    Parkville, Victoria, 3052

    Diana Navarro -Perez, PhD, 03 8345 3721, d.navarroperez@unimelb.edu.au

    Debra Gook, PhD, Senior Investigator

Other trials in Australia

About this study

Official title: 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

Read more

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 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.

Being tested
No intervention
Keywords
Testicular Tissue Grafting, Fertility Preservation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT07915375
Study groupRoleWhat they receive
105 males aged 18 years and above who had testicular tissue cryopreservation at the RCHNot described
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

Secondary outcomes (17)
  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. 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)

    Measured: Baseline

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

    Responses to either disagree or agree.

    Measured: Baseline

  8. Unmet fertility information needs as measured by The Unmet Needs Survey (as used/adapted from Benedicts et al., 2023).

    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.

    Measured: Baseline

  9. 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.

    Measured: Baseline

  10. 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).

    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).

    Measured: Baseline

  11. 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.

    Measured: Baseline

  12. 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.

    Measured: Baseline

  13. Depression as measured by 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.

    Measured: Baseline

  14. Stress as measured by 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.

    Measured: Baseline

  15. 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 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.

    Measured: Baseline

  16. 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.

    Measured: Baseline

  17. Reproductive Goals (as adapted from Lehmann et al., 2017).

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07915375
Sponsor's protocol ID
HREC 130619
Acronym
PACTT
Status last verified
Oct 2026
First submitted
29 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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), participant information and consent form (PICF).

Publications

  • Lehmann V, Keim MC, Nahata L, Shultz EL, Klosky JL, Tuinman MA, Gerhardt CA. Fertility-related knowledge and reproductive goals in childhood cancer survivors: short communication. Hum Reprod. 2017 Nov 1;32(11):2250-2253. doi: 10.1093/humrep/dex297.

    PubMed 29040512
  • Harlan LC, Lynch CF, Keegan TH, Hamilton AS, Wu XC, Kato I, West MM, Cress RD, Schwartz SM, Smith AW, Deapen D, Stringer SM, Potosky AL; AYA HOPE Study Collaborative Group. Recruitment and follow-up of adolescent and young adult cancer survivors: the AYA HOPE Study. J Cancer Surviv. 2011 Sep;5(3):305-14. doi: 10.1007/s11764-011-0173-y. Epub 2011 Jan 28.

    PubMed 21274648
  • Benedict C, Stal J, Davis A, Zeidman A, Pons D, Schapira L, Diefenbach M, Ford JS. Greater fertility distress and avoidance relate to poorer decision making about family building after cancer among adolescent and young adult female survivors. Psychooncology. 2023 Oct;32(10):1606-1615. doi: 10.1002/pon.6212. Epub 2023 Sep 11.

    PubMed 37695291
  • Fayomi AP, Peters K, Sukhwani M, Valli-Pulaski H, Shetty G, Meistrich ML, Houser L, Robertson N, Roberts V, Ramsey C, Hanna C, Hennebold JD, Dobrinski I, Orwig KE. Autologous grafting of cryopreserved prepubertal rhesus testis produces sperm and offspring. Science. 2019 Mar 22;363(6433):1314-1319. doi: 10.1126/science.aav2914.

    PubMed 30898927
  • Safrai M, Goossens E, Mitchell RT, Orwig KE, Mulder CL, van Pelt AMM, Gook DA, Feraille A, Delgouffe E, Ginsberg JP, Stukenborg JB, Duffin K, Jahnukainen K, Andersen CY, van de Wetering MD, Rimmer MP, Barraud-Lange V, Neuhaus N, Lane S, Sadri-Ardekani H, Rives N, Wyns C. Is the time right for transplanting immature testicular tissue or cells to restore male fertility? Expert perspectives on clinical implementation of autotransplantation of cryopreserved testicular tissue or cells for fertility restoration. Best Pract Res Clin Obstet Gynaecol. 2025 Sep;102:102638. doi: 10.1016/j.bpobgyn.2025.102638. Epub 2025 Jul 11.

    PubMed 40695104
  • Khattak H, Malhas R, Craciunas L, Afifi Y, Amorim CA, Fishel S, Silber S, Gook D, Demeestere I, Bystrova O, Lisyanskaya A, Manikhas G, Lotz L, Dittrich R, Colmorn LB, Macklon KT, Hjorth IMD, Kristensen SG, Gallos I, Coomarasamy A. Correction to: Fresh and cryopreserved ovarian tissue transplantation for preserving reproductive and endocrine function: a systematic review and individual patient data meta-analysis. Hum Reprod Update. 2022 May 2;28(3):455. doi: 10.1093/humupd/dmac015. No abstract available.

    PubMed 35285901
  • Rozen G, Sii S, Agresta F, Gook D, Polyakov A, Stern C. Ovarian tissue grafting: Lessons learnt from our experience with 55 grafts. Reprod Med Biol. 2021 May 12;20(3):277-288. doi: 10.1002/rmb2.12380. eCollection 2021 Jul.

    PubMed 34262395

Questions about this trial

What is this clinical trial studying?

An observational study of Fertility and Testicular Tissue Cryopreserved, run by Murdoch Childrens Research Institute at 1 site in Australia.

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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 Australia. 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?

Contact Diana Navarro - Perez, PhD (03 8345 3721, d.navarroperez@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Willingness to consider testicular tissue grafting as measured by responses to a likert scale on the study survey (time frame: Baseline). 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 NCT07915375, which also lists 7 linked publications.

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 4 Nov 2026.

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