UMIN-CTR Clinical Trial

Basic information
Public title	Application of oocyte vitrification to human assisted reproductive technology
Acronym	Application of oocyte vitrification to human assisted reproductive technology
Scientific Title	Application of oocyte vitrification to human assisted reproductive technology
Scientific Title:Acronym	Application of oocyte vitrification to human assisted reproductive technology
Region	Japan

Condition
Condition	malignant disease or hematological disorder
Classification by specialty	Hematology and clinical oncology Breast surgery Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Oocyte cryopreservation by vitrification is performed for patients who are at risk of losing ovarian functions because of treatment for malignant diseases. These patients are able to undergo assisted reproductive techniques with their own oocytes after recovery from treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	successful rate of oocyte cryopreservation. recovery and viability rates after thawing.
Key secondary outcomes	influence on 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 patients undergo controled ovarian stimulation, oocytes are retrieved by ultrasound-guided transvaginal aspiration and cryopreserved by vitrification.
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Women of reproductive age with malignant disease or hematological disorder. Women with regular menstrual cycles. Permission for undergoing oocytes cryopreservation by attending physician for the primary disease is necessary.
Key exclusion criteria	Postmenopausal women. Women who don't have functional uteri. Undergoing oocytes cryopreservation is rejected by attending physician for the primary disease.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yasuhiko Middle name Last name Kamada
Organization	Okayama University Hospital
Division name	Obstetrics and Gynecology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan 700-8558
TEL	086-235-7320
Email	ykamada@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Yasuhiko Middle name Last name Kamada
Organization	Okayama University Hospital
Division name	Obstetrics and Gynecology
Zip code	700-8558
Address	2-5-1 Shikata, Kita-ku, Okayama city
TEL	086-235-7320
Homepage URL
Email	ykamada@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
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)

IRB Contact (For public release)
Organization	Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata, Kita-ku, Okayama city
Tel	086-235-6938
Email	mae6605@adm.okayama-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	岡山大学病院(岡山県），医療法人社団　岡山二人クリニック(岡山県），三宅医院　生殖医療センター(岡山県）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 02 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
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	Open public recruiting
Date of protocol fixation	2011 Year 05 Month 31 Day
Date of IRB	2006 Year 03 Month 15 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2031 Year 05 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	2014 Year 05 Month 02 Day
Last modified on	2020 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006600