UMIN-CTR Clinical Trial

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