UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for cryopreservation and reuse of ovarian tissue and oocytes using ovaries obtained from gender identity disorder patients
Title of the study (Brief title)	Research for cryopreservation and reuse of ovarian tissue and oocytes using ovaries obtained from gender identity disorder patients
Region	Japan North America

Condition
Condition	gender identity disorder
Classification by specialty	Obsterics and gynecology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Establishment of cryopreservation and reuse of ovarian tissue and oocytes and its application to infertility and fertility preservation of cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	viability of transplanted ovarian tissue
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	45 years-old >=
Gender	Female
Key inclusion criteria	Gender identity disorder patients who undergo sex reassignment surgery (hysterectomy and oophorectomy) and provide informed consent to the present research
Key exclusion criteria	Gender identity disorder patients who do not provide informed consent to the research or for whom sex reassignment surgery is contraindicated
Target sample size	100

Research contact person
Name of lead principal investigator	Yasushi Takai
Organization	Saitama Medical Center/ Saitama Medical University
Division name	Department of Obstetrics and Gynecology
Address	1981 Kamoda, Kawagoe, Saitama, Japan
TEL	049-228-3681
Email	yastakai@saitama-med.ac.jp

Public contact
Name of contact person	Yasushi Takai
Organization	Saitama Medical Center/ Saitama Medical University
Division name	Department of Obstetrics and Gynecology
Address	1981 Kamoda, Kawagoe, Saitama, Japan
TEL	049-228-3681
Homepage URL
Email	yastakai@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
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	2016 Year 03 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 05 Month 01 Day
Anticipated trial start date	2011 Year 05 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	Cohort study for GID patients who visit our clinic between May 1, 2011 and March 31, 2016 and are eligible for our study protocol. Ovarian tissue and oocytes obtained by sex reassignment surgery are cryopreserved. Cryopreserved ovarian tissue are thawed and transplanted to immunodeficient mice, and survival rate of oocytes is evaluated. Oogonial stem cells are extracted from cryopreserved ovarian tissue, and utilized for oocyte survival in the transplanted tissue.

Management information
Registered date	2016 Year 03 Month 16 Day
Last modified on	2018 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024795