UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049215 |
|---|---|
| Receipt number | R000056054 |
| Scientific Title | Personalized embryo transfer guided by endometrial receptivity test |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2025/05/21 13:54:11 |
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Basic information
Public title
Clinical relevance of ERPeakSM endometrial receptivity test
Acronym
Clinical relevance of ERPeakSM endometrial receptivity test
Scientific Title
Personalized embryo transfer guided by endometrial receptivity test
Scientific Title:Acronym
Personalized embryo transfer guided by endometrial receptivity test
Region
| Japan |
Condition
Condition
Female infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the effect of personalized embryo transfer guided by ERPeakSM, a new endometrial receptivity test, among recurrent implantation failure patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Live birth rates per embryo transfer cycles
Key secondary outcomes
Clinical Pregnancy and miscarriage rates per embryo transfer cycles
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with recurrent implantation failure.
Key exclusion criteria
Patients with whom consent cannot be obtained. Patients who are recognized as unsuitable by the research director or co-investigator.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Tokyo
Division name
Reproduction Clinic Tokyo
Zip code
105-7108
Address
1-5-2, Higashishimbashi, Minato-ku, Tokyo, Japan
TEL
03-6228-5351
yohara@reposaka.jp
Public contact
Name of contact person
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Tokyo
Division name
Reproduction Clinic Tokyo
Zip code
105-7108
Address
1-5-2, Higashishimbashi, Minato-ku, Tokyo, Japan
TEL
03-6228-5351
Homepage URL
ssumori@reposaka.jp
Sponsor or person
Institute
Reproduction Clinic Tokyo
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Reproduction Clinic Tokyo Research Ethics Committee
Address
1-5-2, Higashishimbashi, Minato-ku, Tokyo, Japan
Tel
03-6228-5351
hyagi@reptokyo.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 19 | 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
471
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The endometrial environment is prepared according to the protocol of frozen-thawed embryo transfer with hormone supplementation and the start date of progesterone supplementation is set to P+0. At P+5, endometrial biopsy is performed to analyze the endometrial receptivity status. RT-qPCR was used on the collected endometrium to examine the expression of 48 types of genes that changed specifically during the implantation phase. Personalized embryo transfer is performed in accordance with theERPeakSM analysis after the next cycle, and the reproductive outcome is evaluated.The intervention group received personalized embryo transfer based on the test results and was compared to control group receiving standardized timing, non-personalized embryo transfer.
Management information
Registered date
| 2022 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056054
