UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020699
Receipt number R000023868
Scientific Title A study for infertility due to female reproductive organs
Date of disclosure of the study information 2016/01/26
Last modified on 2019/01/24 10:41:23

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Basic information

Public title

A study for infertility due to female reproductive organs

Acronym

A study for infertility due to female reproductive organs

Scientific Title

A study for infertility due to female reproductive organs

Scientific Title:Acronym

A study for infertility due to female reproductive organs

Region

Japan


Condition

Condition

hydrosalpinx
endometriosis
uterine fibroid

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate machanism of infertility related to fallopian tube

Basic objectives2

Others

Basic objectives -Others

To elucidate machanism of infertility related to fallopian tube and the impact of intrauterine environment on pregnancy

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Quantitative analysis of inflammatory cytokines in ascites and hydrosalpinx fluid

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients who need to undergo operation due to uterine or ovarian disease and have at least one fallopian tube.

Key exclusion criteria

After bilateral salpingectomy

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Uchida

Organization

Keio University

Division name

Obstetrics and Gynecology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

uchida@a5.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Sato

Organization

Keio University

Division name

Obstetrics and Gynecology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL


Email

ksato@keio.jp


Sponsor or person

Institute

Department of Obstetrics and Gynecology, School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 01 Month 26 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

Completed

Date of protocol fixation

2015 Year 10 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 01 Day

Last follow-up date

2019 Year 01 Month 24 Day

Date of closure to data entry

2019 Year 01 Month 24 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2016 Year 01 Month 22 Day

Last modified on

2019 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023868


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name