UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019590 |
|---|---|
| Receipt number | R000022650 |
| Scientific Title | Assisted reproductive technology using unfertilized oocytes for fertility preservation of young women in malignant diseases |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2016/10/31 19:25:07 |
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Basic information
Public title
Assisted reproductive technology using unfertilized oocytes for fertility preservation of young women in malignant diseases
Acronym
Assisted reproductive technology using unfertilized oocytes for fertility preservation of young women in malignant diseases
Scientific Title
Assisted reproductive technology using unfertilized oocytes for fertility preservation of young women in malignant diseases
Scientific Title:Acronym
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 | Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Tatsuya Suzuki |
Organization
Jichi Medical University
Division name
Department of obstetrics and gynecology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
TEL
0285-58-7376
statsuya@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Suzuki |
Organization
Jichi Medical University
Division name
Department of obstetrics and gynecology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
TEL
0285-58-7376
Homepage URL
statsuya@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
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
Address
Tel
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 |
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
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022650
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
