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
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
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
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
