UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058078 |
|---|---|
| Receipt number | R000065421 |
| Scientific Title | Study on the Diagnosis of Oocyte Aging Using Discarded Cumulus Cells from the Assisted Reproductive Technology Process of In Vitro Fertilization |
| Date of disclosure of the study information | 2025/06/07 |
| Last modified on | 2025/06/04 13:17:46 |
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Basic information
Public title
Assessment of Oocyte aging Using Aging-Associated Chemokine Expression (CXCL5 and CXCR2) in Cumulus Cells
Acronym
Diagnostic Test for Oocyte Aging
Scientific Title
Study on the Diagnosis of Oocyte Aging Using Discarded Cumulus Cells from the Assisted Reproductive Technology Process of In Vitro Fertilization
Scientific Title:Acronym
Diagnostic Test for Oocyte Aging Based on CXCL5 Measurement
Region
| Japan |
Condition
Condition
Advanced-Age Infertility Patients Requiring In Vitro Fertilization
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine whether the expression levels of aging-associated factors in cumulus cells can serve as indicators of oocyte quality. Cumulus cells that are normally discarded during oocyte retrieval in IVF/ICSI procedures will be partially collected and analyzed. Specifically, the expression levels of CXCL5 and its receptor CXCR2 will be measured, and their association with fertilization rate, blastocyst formation, pregnancy outcomes, and chromosomal normality will be evaluated. Additional analyses including p16 (CDKN2A) expression and comprehensive gene expression profiling by RNA sequencing are also planned for selected samples.
Basic objectives2
Others
Basic objectives -Others
Measuring gene expression in cumulus cells that are not needed for treatment to verify whether oocyte aging can be indirectly diagnosed.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between CXCL5 and CXCR2 expression levels in cumulus cells and oocyte developmental outcomes (fertilization rate, blastocyst formation rate, pregnancy outcomes, poregnancy rate, choromosome normality).
Key secondary outcomes
Secondary outcomes include the correlation between CXCL5 and CXCR2 expression levels and patient age, embryo morphological evaluation, ovarian stimulation protocols, and causes of infertility.
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
| 35 | years-old | <= |
Age-upper limit
| 48 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who have provided written informed consent of their own free will after receiving a thorough explanation of the study and fully understanding its contents.
Eligible participants are women aged 35 to 48 years who are scheduled to undergo intracytoplasmic sperm injection (ICSI) and have agreed to provide cumulus cells collected at the time of oocyte retrieval.
Key exclusion criteria
Patients who have not provided written informed consent, unmarried female patients, and those deemed inappropriate for inclusion in the study by the attending physician.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kawamura |
Organization
Juntendo University, Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo, Tokyo, Japan
TEL
03-3813-3111
k.kawamura.aq@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kawamura |
Organization
Juntendo University
Division name
Department of Obstetrics and Gynecology
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
k.kawamura.aq@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Denentoshi ladies clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1, Hongo, Bunkyo, Tokyo, Japan
Tel
03-3813-3111
k.kawamura.aq@juntendo.ac.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
| 2025 | Year | 06 | Month | 07 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a non-interventional observational study using cumulus cells that are normally discarded during IVF/ICSI procedures. The study aims to evaluate the association between aging-related markers (CXCL5, CXCR2, p16, etc.) and oocyte developmental competence. Transcriptome analysis (RNA-seq) is also planned for selected samples.
Management information
Registered date
| 2025 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065421
