UMIN-CTR Clinical Trial

Basic information
Public title	Ovarian Tissue Cryopreservation to improve Quality of Life for the young women with autoimmune disease or cancer.
Acronym	Ovarian Tissue Cryopreservation to improve QOL for the young women with autoimmune disease or cancer.
Scientific Title	Ovarian Tissue Cryopreservation to improve Quality of Life for the young women with autoimmune disease or cancer.
Scientific Title:Acronym	Ovarian Tissue Cryopreservation to improve QOL for the young women with autoimmune disease or cancer.
Region	Japan

Condition
Condition	cancer or autoimmune disease
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish the safe ovarian tissue cryopreservation for fertility preservation of the young women with cancer or autoimmune disease after their therapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.The influence for the main disease;cancer or autoimmune disease, and physical condition. 2.The assessment for the ovarian tissue resected by our clinical research.
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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	(1)Cryopreservation of ovary: vitrification (2)Treatment: addmittion for operation; 3-6days for laparoscopy, 6-10days for laparotomy. Oophorectomy by laparoscopy or laparotomy under general anesthesia. Cyropreservation of ovary with Ova Cryo Kit Type M(KITAZATO CORPORATION). Assessment for ovarian tisuue with H.E. staining.
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	7 years-old <=
Age-upper limit	40 years-old >
Gender	Female
Key inclusion criteria	1.the case who will be ovarian insufficiency with treatment for cancer or autoimmune disease. 2.the case who hopes fertility preservation. 3.the case whose condition is pre or early stage of treatment. 4.the case whose condition is operable by judgment of attending physician. 5.Ageis the above of 7, less than 40 6.the case whose long term prognosis is expected by judgment of attending physician. 7.the case who understood the meaning, merit and demerit of ovarian tissue cryopreservation at our onco-fertility clinic.
Key exclusion criteria	1.the case judged inappropriate by the doctor in charge. 2..the case whose long term prognosis is not expected by judgment of attending physician. 3.the case whose condition is unoperable. 4.the case whose ovary has malignant tissue.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Masahito Middle name Last name Tachibana
Organization	Tohoku university hospital
Division name	Obstetrics and Gynecology department
Zip code	980-8574
Address	1-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7254
Email	masahito555@msn.com

Public contact
Name of contact person	1st name Masahito Middle name Last name Tachibana
Organization	TOHOKU University Hospital
Division name	Obstetrics and Gynecology department
Zip code	980-8574
Address	1-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi
TEL	0227177254
Homepage URL
Email	masahito555@msn.com

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tohoku University Hospital
Address	1-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi
Tel	0227177254
Email	naomit@med.tohoku.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	2019 Year 12 Month 10 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	2019 Year 12 Month 01 Day
Date of IRB	2019 Year 11 Month 11 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2024 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 28 Day
Last modified on	2022 Year 11 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043345