UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013874 |
|---|---|
| Receipt number | 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 09:16:58 |
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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 | Obstetrics 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
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
ykamada@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006600
