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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013874
Receipt No. R000006600
Scientific Title Application of oocyte vitrification to human assisted reproductive technology
Date of disclosure of the study information 2014/05/02
Last modified on 2020/11/05

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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/ctr_e/ctr_view.cgi?recptno=R000006600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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