UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Fertility Preservation for Adolescent and Young Adult Women with cancer by means of Oocyte cryopreservation
Title of the study (Brief title)	Fertility Preservation for Adolescent and Young Adult Women with cancer by means of Oocyte cryopreservation
Region	Japan

Condition
Condition	cancer patient, autoimmune disease patient
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the effectiveness and safety in oocyte cryopreservation for AYA women with cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation for a prospective advantage fertility preservation before cancer treatment Disadvantage is complications with the ovarian stimulation and oocyte pick up
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 Device,equipment Maneuver
Interventions/Control_1	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	16 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	Infertility
Key exclusion criteria	Informed Consent is not obtained
Target sample size	300

Research contact person
Name of lead principal investigator	Shibahara Hiroaki
Organization	Hyogo College of Medicine
Division name	Department of Obstetrics and Gynecology
Address	Hyogo College of Medicine College Hospital, 1-1 Mukogawa-cho, Nishinomiya, HYOGO 653-8501, JAPAN
TEL	+81-798-45-6481
Email	sibahara@hyo-med.ac.jp

Public contact
Name of contact person	Yu Wakimoto
Organization	Hyogo College of Medicine
Division name	Department of Obstetrics and Gynecology
Address	Hyogo College of Medicine College Hospital, 1-1 Mukogawa-cho, Nishinomiya, HYOGO 653-8501, JAPAN
TEL	+81-798-45-6481
Homepage URL
Email	yuuwakimoto@gmail.com

Sponsor
Institute	Hyogo College of Medicine College Hospital
Institute
Department

Funding Source
Organization	Hyogo College of Medicine College 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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 13 Day
Anticipated trial start date	2015 Year 01 Month 13 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 31 Day
Last modified on	2018 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036300