UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019246
Receipt number R000022243
Scientific Title Endometrial gene expression analysis at the time of implantation window in patients with uterine fibroids
Date of disclosure of the study information 2016/01/01
Last modified on 2023/04/26 12:31:42

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Basic information

Public title

Endometrial gene expression analysis at the time of implantation window in patients with uterine fibroids

Acronym

Endometrial gene expression analysis at the time of implantation window in patients with uterine fibroids

Scientific Title

Endometrial gene expression analysis at the time of implantation window in patients with uterine fibroids

Scientific Title:Acronym

Endometrial gene expression analysis at the time of implantation window in patients with uterine fibroids

Region

Japan


Condition

Condition

uterine fibroid

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

This study aimed at identifying new markers assessing endometrial receptivity in patients with uterine fibroids in comparison with controls at the time of implantation window.

Basic objectives2

Others

Basic objectives -Others

Endometrial gene expression analysis at the time of implantation window in patients with uterine fibroids

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

endometrial gene expression in patients with uterine fibroids

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

40 years-old >

Gender

Female

Key inclusion criteria

1)Patients with uterine fibroids
2)Patients with normal menstrual cycle

Key exclusion criteria

1)Patients with endometrial pathologies
2)Patients with patholihies that affects endometrial receptivity
3)Patients who receieved hormonal theraphy

Target sample size



Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Mandai

Organization

Kinki University Faculty of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code


Address

377-2 Ohno-Higashi Osakasayama Osaka

TEL

072-366-0221

Email

mandai@med.kindai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Isao Tsuji

Organization

Kinki University Faculty of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code


Address

377-2 Ohno-Higashi Osakasayama Osaka

TEL

072-366-0221

Homepage URL


Email

i-tsuji@med.kindai.ac.jp


Sponsor or person

Institute

Department of Obstetrics and Gynecology, Kinki University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Obstetrics and Gynecology, Kinki University Faculty 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

2016 Year 01 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

Completed

Date of protocol fixation

2015 Year 10 Month 05 Day

Date of IRB

2015 Year 10 Month 14 Day

Anticipated trial start date

2016 Year 01 Month 01 Day

Last follow-up date

2020 Year 10 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Since January 1 2016, patients with uterine fibroids who visit Kinki University Hospital


Management information

Registered date

2015 Year 10 Month 06 Day

Last modified on

2023 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022243


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name