UMIN-CTR Clinical Trial

Basic information
Public title	Preservation of fertility by cryopreservation of ovarian tissue and autologous transplantation of ovarian tissue in premenopausal women diagnosed with malignant tumors
Acronym	Preservation of fertility by cryopreservation of ovarian tissue in premenopausal women
Scientific Title	Preservation of fertility by cryopreservation of ovarian tissue and autologous transplantation of ovarian tissue in premenopausal women diagnosed with malignant tumors
Scientific Title:Acronym	Preservation of fertility by cryopreservation of ovarian tissue in premenopausal women
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 Obsterics and gynecology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Preserve of fertility
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fertility by autologous transplantation of cryopreserved ovarian tissue
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	18 years-old <=
Age-upper limit	41 years-old >=
Gender	Female
Key inclusion criteria	Patients must: 1 meet the disease and age criteria 2 has consented the study in a written form 3 be under the age 45 and obtain another written consent by the physician treating her primary disease at the time of autotransplantation 4 make an annual visit to the clinic during the period requiring cryopreservation
Key exclusion criteria	Cryopreservation and autotransplantation 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	100

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

Sponsor
Institute	Mie University Hospital
Institute
Department

Funding Source
Organization	Mie University Hospital
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	Medical Research Ethics Committee, Mie University Hospital
Address	2-174 Edobashi, Tsu, Mie, Japan
Tel	059-232-1111
Email	s-kenkyu@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	2017 Year 11 Month 14 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	5
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	Terminated
Date of protocol fixation	2017 Year 08 Month 24 Day
Date of IRB	2017 Year 06 Month 08 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2022 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	2017 Year 11 Month 10 Day
Last modified on	2020 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034179