UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Autotransplantation and culture of cryopreserved ovarian tissue in patients with cancer or immunologic diseases to preserve fertility.
Title of the study (Brief title)	Autotransplantation and culture of cryopreserved ovarian tissue
Region	Japan

Condition
Condition	Breast cancer, leukemia, malignant lymphoma (Hodgkin's and Non-Hodgkin's), other hematopoietic diseases (hypoplastic anemia, myelodysplastic syndrome, myeloma), sarcoma, systemic lupus erythematosus, rheumatic arthritis and other diseases requiring alkylating agents or radiation therapies.
Classification by specialty	Medicine in general Surgery in general
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	to preserve fertility
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fertility by autotransplantation of cryopreserved ovarian tissue
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	45 years-old >=
Gender	Female
Key inclusion criteria	Patients must meet all of the following: 1 meets the disease and age criteria 2 has a signed informed and consent form 3 as for autotransplantation, must be equal to or under the age 50 and must have a signed consent by the physician treating the primary disease 4 must make an annual visit to the clinic during the period requiring cryopreservation
Key exclusion criteria	Exclusion criteria for cryopreservation: 1 has a serious complication 2 inability to judge or unable to confirm his/her wishes 3 if this study will delay the treatment for the primary disease 4 other situations where the physician treating the primary disease decides the patient unfit for this study Exclusion criteria for autotransplantation: 1 has a serious complication 2 inability to judge or unable to confirm his/her wishes 3 if autotransplantation is a risk for the patient
Target sample size	50

Research contact person
Name of lead principal investigator	Akira Iwase
Organization	Nagoya University Hospital
Division name	Perinatal Medical Center
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2261
Email	akiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tomoko Nakamura
Organization	Nagoya University Hospital
Division name	Department of Obstetrics and Gynecology
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2261
Homepage URL
Email	tomonakamura@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital Department of Obstetrics and Gynecology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nagoya University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2014 Year 08 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 05 Month 12 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 12 Day
Last modified on	2016 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016238