UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023141 |
|---|---|
| Receipt number | R000026676 |
| Scientific Title | Verification of accuracy for ovarian reserve assessment with optical coherence tomography. |
| Date of disclosure of the study information | 2016/07/13 |
| Last modified on | 2021/07/17 12:32:42 |
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Basic information
Public title
Verification of accuracy for ovarian reserve assessment with optical coherence tomography.
Acronym
Verification of accuracy for ovarian reserve assessment with optical coherence tomography.
Scientific Title
Verification of accuracy for ovarian reserve assessment with optical coherence tomography.
Scientific Title:Acronym
Verification of accuracy for ovarian reserve assessment with optical coherence tomography.
Region
| Japan |
Condition
Condition
Cancer, Collagen disease, Primary Ovarian Insufficiency
Classification by specialty
| Hematology and clinical oncology | Clinical immunology | Breast surgery |
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In present study, we conducted experiments with latest OCT equipment, to establish the standard images of follicles on each
developmental stage with OCT, to assess the accuracy of OCT to estimate ovarian reserve like as histological image.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological image of ovary
Key secondary outcomes
AMH level
Besal FSH level
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Extracted ovaries for fertility preservation or fertility treatment, were examined
with OCT before histological examination.
Ovaries will received OCT examination
just one time before formalin fixation.
OCT examination takes around 15 minutes to create image.
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
| 18 | years-old | <= |
Age-upper limit
| 46 | years-old | >= |
Gender
Female
Key inclusion criteria
1,Cancer or Collagen disease patients,
or Primary ovarian insufficiency patients who hope to ovarian tissue cryopreservation for fertility preservation or fertility treatment.
2,The patients who permitted to receive fertility preservation treatment by primary doctor.
Key exclusion criteria
1,The patient who was not expected long-term survival.
Target sample size
5
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 prefecture, 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 prefecture, 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
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa prefecture, JAPAN
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
3311
Org. issuing International ID_1
St. Marianna University School of Medicine
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（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29607457
Number of participants that the trial has enrolled
Results
OCT examination may assess the ovarian reserve on each ovarian tissues. To assess properly, some investigation is needed.
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
| 2016 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now we will conduct this investigation for limited contributors.
Management information
Registered date
| 2016 | Year | 07 | Month | 13 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026676
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
