Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue (PACTT)
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)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Diana Navarro - Perez, PhD
- 電話番号：03 8345 3721
- メール：d.navarroperez@unimelb.edu.au
研究場所
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Victoria
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Parkville、Victoria、オーストラリア、3052
- Murdoch Children's Research Institute
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コンタクト：
- Diana Navarro -Perez, PhD
- 電話番号：03 8345 3721
- メール：d.navarroperez@unimelb.edu.au
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副調査官：
- Debra Gook, PhD, Senior Investigator
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副調査官：
- Margaret Zacharin, MBBS, FRACP, PhD
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副調査官：
- Michael Assis, PhD, Postdoc Research Fellow
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副調査官：
- Hossam Elzeiny, MB ChB, AMC Certificate, FRANZ
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副調査官：
- Zobaida Edib, PhD, Postdoc Research Fellow
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副調査官：
- Apoorva Bhargava, MPH, Research Fellow
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副調査官：
- Diana Navarro - Perez, PhD, MSc
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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105 males aged 18 years and above who had testicular tissue cryopreservation at the RCH
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No intervention |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Willingness to consider testicular tissue grafting as measured by responses to a likert scale on the study survey
時間枠：Baseline
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：Baseline
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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
時間枠：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
|
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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
時間枠：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
|
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Willingness to consider testicular tissue grafting according to perceived potential beneficial outcomes as measured by responses to a likert scale on the study survey
時間枠：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
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Willingness to consider testicular tissue grafting according to perceived safety as measured by responses to a likert scale on the study survey
時間枠：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
|
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Perceived social pressure from partners, parents, general practitioners (GP) and religious leaders as measured by responses to the Theory of Planned Behaviour questionnaire.
時間枠：Baseline
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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
|
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Perceived behavioural control as measured by responses to the Theory of Planned Behaviour questionnaire.
時間枠：Baseline
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Responses to either disagree or agree. |
Baseline
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Unmet fertility information needs as measured by The Unmet Needs Survey (as used/adapted from Benedicts et al., 2023).
時間枠：Baseline
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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).
時間枠：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).
時間枠：Baseline
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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
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Financial toxicity survey as measured by the Comprehensive Score for Financial Toxicity (COST).
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Optimism as measured by the adapted Life Orientation Scale.
時間枠：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
|
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Medical Decision-Making preferences as measured by the Control Preferences Scale
時間枠：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
|
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Reproductive Goals (as adapted from Lehmann et al., 2017).
時間枠：Baseline
|
Reproductive goals are assessed using 5 items categorising responses between yes, no or unsure. |
Baseline
|
協力者と研究者
捜査官
- 主任研究者：Yasmin Jayasinghe, MBBS, FRANZCOG, PhD、University of Melbourne
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HREC 130619
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Following analysis and article publication.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- ICF
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米国FDA規制機器製品の研究
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