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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023141
Receipt No. 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 2020/07/15

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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
Obsterics 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
Email 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
Email s2takae@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
Email 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

Management information
Registered date
2016 Year 07 Month 13 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026676

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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