UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034811 |
|---|---|
| Receipt number | R000039700 |
| Scientific Title | Gene expression analysis in maturation process of human oocyte |
| Date of disclosure of the study information | 2018/11/08 |
| Last modified on | 2025/11/17 10:27:17 |
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Basic information
Public title
Gene expression analysis in maturation process of human oocyte
Acronym
Search for developmental biomarker of human oocyte
Scientific Title
Gene expression analysis in maturation process of human oocyte
Scientific Title:Acronym
Search for developmental biomarker of human oocyte
Region
| Japan |
Condition
Condition
oocyte treated as infertility treatment
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In recent years, infertile patients have increased significantly in developed countries including Japan, and the number of infertile patients has reached one pair out of six. For that reason, reproductive auxiliary medical technologies such as in vitro fertilization, micro-insemination, in vitro culture, etc. are being studied and conducted all over the world, but the pregnancy and childbirth rate continues to decline at present. In this study, in order to improve the in vitro maturation method of human oocyte, we extensively investigated the gene expression of in vitro maturation oocytes to identify genes involved in normal oocyte maturation and high generation ability based on its expression to establish a selection method for in vitro maturing oocytes.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Result of transcriptome analysis
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1) Immature oocytes determined to be unmatured in the second meiotic division within the prescribed oocytes to be destroyed or prescribed in vitro maturation treatment of patients who have taken oocytes by infertility treatment, and determined to be discarded
2) Following informed consent sufficient to participate in this research, document agreement by the patient's free will is obtained
Key exclusion criteria
1) Patients who are judged inappropriate as research subjects by the research director or research co-investigator
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Erina |
| Middle name | |
| Last name | Takayama |
Organization
Mie university
Division name
Mie university hospital
Zip code
514-8507
Address
2-174 Edobashi Tsu, Mie
TEL
059-232-1111
erina-t@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takeuchi |
Organization
Mie univercity
Division name
Graduate School, Faculity of Medicine
Zip code
514-8507
Address
2-174 Edobashi Tsu, Mie
TEL
059-232-1111
Homepage URL
h-takeuchi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie university
Institute
Department
Personal name
Funding Source
Organization
The 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
Faculty of Biology-Oriented Science and Technology, Kindai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, School of Medicine Hospital , Mie University
Address
2-174 Edobashi Tsu, Mie
Tel
059-232-1111
s-kenkyu@mo.medic.mie-u.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
三重大学医学部附属病院高度生殖医療センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/rmb2.12464
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/rmb2.12464
Number of participants that the trial has enrolled
11
Results
During in vitro maturation of human oocytes, hundreds of transcripts exhibited dynamic changes, and genes whose expression increased at each maturation stage were identified. Moreover, even oocytes at the same maturation stage showed differences in gene expression profiles.
Results date posted
| 2025 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Human immature oocytes from 11 patients were collected; detailed baseline characteristics of the patients (age, collection time, number of oocytes per patient) are reported only in limited detail.
Participant flow
Nineteen immature oocytes were collected from 11 subjects, and some were cultured to maturity in vitro. Subsequently, each oocyte underwent RNA-seq analysis at the single-cell level.
Adverse events
none
Outcome measures
Single-cell RNA-seq gene expression profiles of individual oocytes
Changes in transcripts at each maturation stage during IVM
Analysis of gene expression differences among oocytes at the same maturation stage
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search for biomarkers that are indicators of human ovum development
Management information
Registered date
| 2018 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039700
