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 2023/11/12 16:47:59

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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

Email

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

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

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

2023 Year 11 Month 12 Day



Link to view the page

Value
https://center6.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