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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026823
Receipt No. R000030789
Scientific Title The effect of menstrual cycle on regulatory T cells in normal and infertile women.
Date of disclosure of the study information 2017/04/01
Last modified on 2017/07/27

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Basic information
Public title The effect of menstrual cycle on regulatory T cells in normal and infertile women.
Acronym The effect of menstrual cycle on regulatory T cells.
Scientific Title The effect of menstrual cycle on regulatory T cells in normal and infertile women.
Scientific Title:Acronym The effect of menstrual cycle on regulatory T cells.
Region
Japan

Condition
Condition infertility
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between menstrual cycle and regulatory T cells (Treg) in normal control and infertile women.
Basic objectives2 Others
Basic objectives -Others To investigate the phisiological role of Treg
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subpopulations of Treg in peripheral blood in different menstrual cycle.
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
45 years-old >
Gender Female
Key inclusion criteria Control women whose menstrual cycle is regular
Infertile women undergoing ART.
Key exclusion criteria Women who doesn't use oral contraceptives.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Okimura
Organization Kyoto Prefectural University of Medicine
Division name Department of obstetrics and gynecology
Zip code
Address Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL 075-251-5560
Email h-okim@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Okimura
Organization Kyoto Prefectural University of Medicine
Division name Department of obstetrics and gynecology
Zip code
Address Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL 075-251-5560
Homepage URL
Email h-okim@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We aimed to investigate the changes of subpopulation of Treg in menstrual cycle in peripheral blood.

Management information
Registered date
2017 Year 04 Month 01 Day
Last modified on
2017 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030789

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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