UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048346 |
|---|---|
| Receipt number | R000055105 |
| Scientific Title | Cryopreservation of oocyte as fertility preservation for girls who are expected to have decreased fertility (a case of primary ovarian insufficiency due to precocious puberty) |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2022/07/12 10:50:28 |
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Basic information
Public title
Cryopreservation of oocyte as fertility preservation for girls who are expected to have decreased fertility (a case of primary ovarian insufficiency due to precocious puberty)
Acronym
Cryopreservation of oocyte as fertility preservation for girls who are expected to have decreased fertility (a case of primary ovarian insufficiency due to precocious puberty)
Scientific Title
Cryopreservation of oocyte as fertility preservation for girls who are expected to have decreased fertility (a case of primary ovarian insufficiency due to precocious puberty)
Scientific Title:Acronym
Cryopreservation of oocyte as fertility preservation for girls who are expected to have decreased fertility (a case of primary ovarian insufficiency due to precocious puberty)
Region
| Japan |
Condition
Condition
precocious puberty, primary ovarian insufficiency
Classification by specialty
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cryopreserve the oocyte of patients who are expected to lose fertility, leaving the possibility of future pregnancy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of retrieved oocyte
Key secondary outcomes
Complication
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 14 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Female
Key inclusion criteria
The diagnosis of precocious puberty
Loss of fertility
Key exclusion criteria
If the person does not wish
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku,Kawasaki city, Kanagawa JAPAN
TEL
044-977-8111
nao@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Seido |
| Middle name | |
| Last name | Takae |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku,Kawasaki city, Kanagawa JAPAN
TEL
044-977-8111
Homepage URL
s2takae@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review oard of St. Marianna University
Address
2-16-1 Sugao, Miyamae-ku,Kawasaki city, Kanagawa JAPAN
Tel
044-977-8111
k-sienbu.mail@marianna-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
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Oocyte cryopreservation will be performed on only one target case to evaluate its efficacy and safety. The reason is that the patient is a pubertal girl and the disease is precocious puberty. In the future, we plan to consider opportunities for oocyte collection multiple times.
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055105
