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.
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
- Conditions the study is for
- Fertility, Testicular Tissue Cryopreserved, Fertility Preservation
- 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.
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
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 group | Role | What they receive |
|---|---|---|
| 105 males aged 18 years and above who had testicular tissue cryopreservation at the RCH | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
Perceived behavioural control as measured by responses to the Theory of Planned Behaviour questionnaire.
Responses to either disagree or agree.
Measured: Baseline
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
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
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
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
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
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
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
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
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
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.
- First posted4 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne
- Responsible party
- Sponsor
- Investigators
- Yasmin Jayasinghe, MBBS, FRANZCOG, PhD, Principal investigator, University of Melbourne
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 29040512Harlan 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 21274648Benedict 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 37695291Fayomi 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 30898927Safrai 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 40695104Khattak 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 35285901Rozen 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue (PACTT)
- ClinicalTrials.gov ID
- NCT07915375
- Acronym / sponsor ID
- PACTT / HREC 130619
- Keywords
- Testicular Tissue Grafting, Fertility Preservation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- University of Melbourne
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Nov 2026 (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.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 105 males aged 18 years and above who had testicular tissue cryopreservation at the RCH | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Deceased patients
- Patients currently undergoing active gonadotoxic cancer treatment.
- Patients who are palliative
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 |
|---|---|---|
| No interventionNo intervention | Other | 105 males aged 18 years and above who had testicular tissue cryopreservation at the RCH |
Primary outcome
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.
17 secondary outcomes
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 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 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 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 consider testicular tissue grafting according to perceived safety as measured by responses to a likert scale on the study survey
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.
Time frame: Baseline
Perceived behavioural control as measured by responses to the Theory of Planned Behaviour questionnaire.
Time frame: Baseline
Unmet fertility information needs as measured by The Unmet Needs Survey (as used/adapted from Benedicts et al., 2023).
Time frame: Baseline
Decisional Conflict as measured by the Decisional Conflict Scale (DCS).
Time frame: 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
Financial toxicity survey as measured by the Comprehensive Score for Financial Toxicity (COST).
Time frame: Baseline
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 6a
Time frame: Baseline
Depression as measured by PROMIS 6a
Time frame: Baseline
Stress as measured by PROMIS 8a
Time frame: Baseline
Optimism as measured by the adapted Life Orientation Scale.
Time frame: Baseline
Medical Decision-Making preferences as measured by the Control Preferences Scale
Time frame: Baseline
Reproductive Goals (as adapted from Lehmann et al., 2017).
Time frame: Baseline
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 4 Nov 2026.
- Background: PubMed 29040512Lehmann 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.
- Background: PubMed 21274648Harlan 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.
- Background: PubMed 37695291Benedict 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.
- Background: PubMed 30898927Fayomi 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.
- Background: PubMed 40695104Safrai 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.
- Background: PubMed 35285901Khattak 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.
- Background: PubMed 34262395Rozen 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.
- Individual participant dataSharing planned: 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).
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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.
Yasmin Jayasinghe, MBBS, FRANZCOG, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
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.