UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026823
Receipt number 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 22:30:57

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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

Obstetrics 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 or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



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

Value
https://center6.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