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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034811
Receipt No. R000039700
Official scientific title of the study Gene expression analysis in maturation process of human oocyte
Date of disclosure of the study information 2018/11/08
Last modified on 2018/11/08

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Basic information
Official scientific title of the study Gene expression analysis in maturation process of human oocyte
Title of the study (Brief title) Search for developmental biomarker of human oocyte
Region
Japan

Condition
Condition oocyte treated as infertility treatment
Classification by specialty
Obsterics 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 Kei Miyamoto
Organization Kindai university
Division name Biology-Oriented Science and Technology
Address 930 nishimitani kinokawa city, wakayama
TEL 0736-77-3888
Email kmiyamo@waka.kindai.ac.jp

Public contact
Name of contact person Hiroki Takeuchi
Organization Mie univercity
Division name Graduate School, Faculity of Medicine
Address 2-174 Edobashi Tsu, Mie
TEL 059-232-1111
Homepage URL
Email h-takeuchi@clin.medic.mie-u.ac.jp

Sponsor
Institute Kindai university
Institute
Department

Funding Source
Organization The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 07 Day
Anticipated trial start date
2018 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039700

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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