UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026676