UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Oocyte cryopreservation for fertility preservation of young woman in cancer, immune disease and the premature ovarian insufficiency
Title of the study (Brief title)	Oocyte cryopreservation for fertility preservation
Region	Japan

Condition
Condition	Cancer patient including hematological malignancy, autoimmune disease such as SLE, premature ovarian insufficiency
Classification by specialty	Medicine in general Gastroenterology Pneumology Endocrinology and Metabolism Hematology and clinical oncology Nephrology Clinical immunology Surgery in general Gastrointestinal surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Pediatrics Dermatology Oto-rhino-laryngology Orthopedics Urology Radiology Oral surgery Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Verification of the effectiveness and safety in unfertilized oocyte cryopreservation as a clinical study for a fertility preservation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation for a prospective advantage and disadvantage (including complication resulting from ovarian stimulation)
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	Medicine
Interventions/Control_1	All the patients receive the same medical intervention Period (routine ovarian stimulation) Dosage of medicine (different among individuals) Number of times (1-2 times of oocyte pick up)
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	15 years-old <=
Age-upper limit	39 years-old >=
Gender	Female
Key inclusion criteria	Long-term survival is anticipated. 15 years or older 39 years or younger
Key exclusion criteria	An agreement is not obtained Patient who is judged to be inappropriate for this study Patient for whom the start of therapy may be significantly delayed for this study
Target sample size	30

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
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
TEL	049-228-3681
Homepage URL
Email	yastakai@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical Center, Saitama Medical University
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	2015 Year 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 12 Month 10 Day
Anticipated trial start date	2015 Year 02 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 12 Month 10 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018518