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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039717
Receipt No. R000045298
Scientific Title Single facility prospective study on fertility-preserving treatment by cryopreservation of ovarian tissue and autologous ovarian tissue transplantation for CAYA generation patients on the premise of treatment likely to abolish gonad function
Date of disclosure of the study information 2020/03/05
Last modified on 2020/05/11

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Basic information
Public title Single facility prospective study on fertility-preserving treatment by cryopreservation of ovarian tissue and autologous ovarian tissue transplantation for CAYA generation patients on the premise of treatment likely to abolish gonad function
Acronym CAYA ovary cryopreservation study
Scientific Title Single facility prospective study on fertility-preserving treatment by cryopreservation of ovarian tissue and autologous ovarian tissue transplantation for CAYA generation patients on the premise of treatment likely to abolish gonad function
Scientific Title:Acronym CAYA ovary cryopreservation study
Region
Japan

Condition
Condition 1. Hematopoietic malignancy (Hodgkin's lymphoma, etc.)
2. Cervical cancer (Squamous cell carcinoma)
3. Breast cancer
4. Rare cancer other than hematopoietic malignancy
5. Hematological diseases requiring hematopoietic cell transplantation (Aplastic anemia, etc.) or autoimmune diseases
Classification by specialty
Medicine in general Surgery in general Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examination of usefulness of fertility- preservation by ovarian cryopreservation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Birth rate in cryopreserved ovarian tissue autotransplant population
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 cryopreservation of ovarian tissue
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
3 years-old <=
Age-upper limit
45 years-old >
Gender Female
Key inclusion criteria 1) Patients aged between 3 and 40 years old at the time of cryopreservation of ovarian tissue and between 18 and 45 years old at the time of ovarian tissue transplantation (transplantation over 45 years is not recomended by the guidelines of the Japanese Society of Reproductive Medicine)
2) Hematopoietic malignancies (Hodgkin's lymphoma, etc.), cervical cancer (squamous cell carcinoma), breast cancer, rare cancers other than hematopoietic malignancies, blood diseases requiring hematopoietic cell transplantation (aplastic anemia, etc.) or autoimmunity Patient diagnosed with the disease
3) Patients judged by the attending physician to have a potential remission of the underlying disease
4) Patients with Performance Status (PS; criteria for establishing the Eastern Cooperative Oncology Group (ECOG)) of 0-1
5) Patients who have been fully informed of the contents of this study using the prescribed consent document and other explanatory documents, and who voluntarily agree to participate in this study in writing Patients who have been obtained)
6) Patients who can undergo ovariectomy within 2 weeks after explanation and consent
Key exclusion criteria 1) Patients with a high probability of metastasis of the original disease to the ovary
2) Patients with obvious infections
3) Patients with severe uncontrollable complications
4) Patients whose doctor judges that this study is inappropriate for participation
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Ikeda
Organization Mie University
Division name Department of Obstetrics and Gynecology, Mie univercity hospital
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie, Japan
TEL 059-232-1111
Email t-ikeda@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Tadashi
Middle name
Last name Maezawa
Organization Mie University
Division name Department of Obstetrics and Gynecology, Mie univercity hospital
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie, Japan
TEL 059-232-1111
Homepage URL http://www.medic.mie-u.ac.jp/oncofertility/index.html
Email mie-oncofertility@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University
Institute
Department

Funding Source
Organization Mie University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the Clinical Research Ethics Review Committee of Mie University Hospital
Address 2-174 Edobashi, Tsu, Mie, Japan
Tel 059-232-1111
Email kk-sien@mo.medic.mie-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2020 Year 03 Month 05 Day
Date of IRB
2020 Year 03 Month 24 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 05 Day
Last modified on
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045298

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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