UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assisted reproductive technology using unfertilized oocytes for fertility preservation of young women in malignant diseases
Title of the study (Brief title)	Assisted reproductive technology using unfertilized oocytes for fertility preservation of young women in malignant diseases
Region	Japan

Condition
Condition	Malignant disease
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Endocrinology and Metabolism Hematology and clinical oncology Nephrology Clinical immunology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Pediatrics Ophthalmology 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 assisted reproductive technology using unfertilized oocytes for fertility preservation of young women in malignant diseases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Implantation rate, pregnancy rate and live birth rate
Key secondary outcomes	Viability rate and fertilization rate after thawing Perinatal complication Prognosis of the primary disease

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 Device,equipment Maneuver
Interventions/Control_1	After controlled ovarian stimulation, oocytes are retrieved by ultrasound-guided transvaginal aspiration and cryopreserved
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	16 years-old <=
Age-upper limit	39 years-old >=
Gender	Female
Key inclusion criteria	Long-term survival is anticipated. 16 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
Target sample size	40

Research contact person
Name of lead principal investigator	Tatsuya Suzuki
Organization	Jichi Medical University
Division name	Department of obstetrics and gynecology
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
TEL	0285-58-7376
Email	statsuya@jichi.ac.jp

Public contact
Name of contact person	Tatsuya Suzuki
Organization	Jichi Medical University
Division name	Department of obstetrics and gynecology
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
TEL	0285-58-7376
Homepage URL
Email	statsuya@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	None
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 12 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2015 Year 12 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	2015 Year 11 Month 01 Day
Last modified on	2016 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022650