UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048694 |
|---|---|
| Receipt number | R000055484 |
| Scientific Title | A study of fertilized embryos observation and evaluation methods using optical coherence tomography (OCT) technology |
| Date of disclosure of the study information | 2022/08/18 |
| Last modified on | 2024/03/05 16:47:22 |
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Basic information
Public title
A study of fertilized embryos observation and evaluation methods using three-dimensional observation technology
Acronym
A study of three-dimensional observation and evaluation of fertilized embryos
Scientific Title
A study of fertilized embryos observation and evaluation methods using optical coherence tomography (OCT) technology
Scientific Title:Acronym
A study of optical coherence tomography observation and evaluation of fertilized embryos
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Optical microscopes have traditionally been used to observe fertilized embryos. Embryos are graded according to the Veeck and Gardner classifications to achieve good implantation rates. This is qualitative data that requires the skill of doctors and embryologists and is also based on the clinic's accumulated experience.
Recently, incubator-equipped observation devices with time-lapse functions have appeared, and attempts are being made to obtain quantitative data from two-dimensional images and to evaluate embryos by using developmental time as a parameter. However, such quantitative measurements of fertilized embryos are not a practical way to assess the quality of fertilized eggs and are limited to two-dimensional measurements of the three-dimensional overall structure.
Optical coherence tomography (OCT) technology is used in ophthalmology to examine the fundus of the eye, and SCREEN has demonstrated in animal experiments a method of acquiring quantitative data based on three-dimensional observation of fertilized eggs using the device.
In this study, fertilized embryos obtained by assisted reproductive technology (ART) at Miyake Clinic will be observed with an OCT observation device simultaneously with or as an alternative to the conventional method during conventional microscopic observation, and the embryos judged to be the best by each method are transferred and the implantation rate, miscarriage rate and production rate will be compared. SCREEN will perform statistical analysis of the quantitative data obtained from the physician's judgment and the OCT observation equipment. Image data will be used for software optimization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implantation rate
Key secondary outcomes
Developmental rate to the blastocyst stage, miscarriage rate and production rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Selection of embryos to be transferred by microscopic observation (Control)
Interventions/Control_2
Selection of embryos to be transferred by OCT observation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Embryos obtained from patients who wish to undergo IVF or ICSI, as determined by the doctor or embryologist to be free of infection and with a sufficient number of eggs retrieved.
Key exclusion criteria
Unfertilized embryos, arrested embryos
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Oda |
Organization
Miyake Clinic
Division name
Center for Reproductive Medicine
Zip code
701-0204
Address
369-8 Ofuku, Minami-ku, Okayama-shi, Okayama 701-0204, Japan
TEL
086-282-5100
ivf@miyakegroup.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Oda |
Organization
Miyake Clinic
Division name
Center for Reproductive Medicine
Zip code
701-0204
Address
369-8 Ofuku, Minami-ku, Okayama-shi, Okayama 701-0204, Japan
TEL
086-282-5100
Homepage URL
ivf@miyakegroup.jp
Sponsor or person
Institute
Miyake Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
SCREEN Holdings Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyake Clinic Ethics Committee
Address
369-8 Ofuku, Minami-ku, Okayama-shi, Okayama 701-0204, Japan
Tel
086-282-7532
ivf@miyakegroup.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
三宅医院（岡山県）、株式会社SCREENホールディングス（京都府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 18 | 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
400
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
Terminated
Date of protocol fixation
| 2019 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055484
