UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053312 |
|---|---|
| Receipt number | R000060846 |
| Scientific Title | Verification of the effectiveness of ovarian reserve assessment using optical coherence tomography (SS-OCT) |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/01/10 16:43:08 |
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Basic information
Public title
Verification of the effectiveness of ovarian reserve assessment using optical coherence tomography (SS-OCT)
Acronym
Verification of the effectiveness of ovarian reserve assessment using optical coherence tomography (SS-OCT)
Scientific Title
Verification of the effectiveness of ovarian reserve assessment using optical coherence tomography (SS-OCT)
Scientific Title:Acronym
Verification of the effectiveness of ovarian reserve assessment using optical coherence tomography (SS-OCT)
Region
| Japan |
Condition
Condition
Malignant disease, Cancer, Breast cancer, Hematologial disease, Leukemia, pediatric cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Breast surgery |
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of SS-OCT in detecting minimal residual disease in ovaries extracted for fertility preservation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We will image the follicle using OCT and create a standard image.
Follicle number counting by OCT (primordial follicle, primary follicle, secondary follicle, antral follicle)
Correlation with ovarian histological examination, blood AMH level, and other ovarian reserve tests
Key secondary outcomes
We will also verify whether it is possible to confirm the presence or absence of malignant tumors.
In cases where ovarian tissue transplantation is performed, the period until ovarian function recovers after ovarian transplantation, the number of oocytes obtained after ovarian transplantation, fertilization rate, and clinical pregnancy rate (confirmation of gestational sac) are evaluated.
If animal experiments are conducted, evaluation items include ovarian function recovery rate, recovery period, number of oocytes collected, and abnormality of oocytes (a separate application will be submitted as an animal experiment).
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
| Not applicable |
Age-upper limit
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who have undergone ovarian tissue freezing must have received an explanation of the content of this study, fully understood it, and, in principle, obtained free written consent from the patient and their relatives, including their spouse or guardian. To be there. In cases where the patient has already died, the above-mentioned relatives must be informed and their consent obtained.
Key exclusion criteria
If the patient or family has expressed opposition to donating the tissue to research at the time of ovarian tissue freezing.
If patient consent is not obtained for ovarian tissue to be performed.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | SEIDO |
| Middle name | |
| Last name | TAKAE |
Organization
St. Marianna University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki city, Kanagawa JAPAN
TEL
044-977-8511
s2takae@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
Obstetrics and Gynecology
Zip code
216-8511
Address
Sugao 2-16-1, 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
SEIDO TAKAE
Funding Source
Organization
N/A
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
Certified Review Board of St. Marianna University
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki city, Kanagawa JAPAN
Tel
044-977-81111
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ovarian tissue will be frozen and specimens from patients whose tissues are no longer needed (including deceased cases) will be used.
At that time, the content of this study will be explained to the patient (or relative in the case of death) and consent will be obtained.
Test results will be reported in papers, etc.
This study is a one-arm study with no controls, and the purpose is to confirm the usefulness of SS-OCT.
If the effectiveness of this method is to be verified using experiments using animals, separate permission for animal experiments must be obtained.
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060846
