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
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
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
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
