UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039717 |
|---|---|
| Receipt number | 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 11:37:24 |
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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 | Obstetrics 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
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
mie-oncofertility@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045298
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
