UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031731 |
|---|---|
| Receipt number | R000036121 |
| Scientific Title | Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2018/03/17 19:34:42 |
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Basic information
Public title
Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Acronym
Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Scientific Title
Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Scientific Title:Acronym
Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Region
| Japan |
Condition
Condition
infertility and recurrent miscarriage
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the etiology of nfertility and recurrent miscarriage using vaginal and uterine microbiota
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between microbiota and implantation rate and livebirth rate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
vaginal and uterine cavity secretion and endometrial tissue collection from test subjects
Interventions/Control_2
vaginal and uterine cavity secretion and endometrial tissue collection from test subjects after treatments by antibiotics and/or probiotics/prebiotics administration
<antibiotics>
1. doxycycline 200mg (100mg tablet, twice a day) for 14 days
2. ciprofloxacin 600mg(200mg tablet, three times a day) for 10 days
3. amoxicillin 1000mg(250mg capsule, four times a day) for 8 days
4. josamycin 1200mg(200mg two tablets, three times a day) for 12 days
<probiotics/prebiotics>
1. lactoferrin 700mg(100mg seven tablets, once time a day ) for more than four weeks
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
Infertile patients requiring artificial reproductive technology and recurrent miscarriage patients
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuhiko Ichiyama |
Organization
St.Mother Hospital
Division name
Department of obstetrics and gynecology
Zip code
Address
4-9-12 Orio Yahatanishi-ku Kitakyusyu city Fukuoka Japan
TEL
81-93-601-2000
peacety0218@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuhiko Ichiyama |
Organization
St.Mother Hospital
Division name
Department of obstetrics and gynecology
Zip code
Address
4-9-12 Orio Yahatanishi-ku Kitakyusyu city Fukuoka Japan
TEL
81-93-601-2000
Homepage URL
incho@stmother.com
Sponsor or person
Institute
St.Mother Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2018 | Year | 03 | Month | 15 | 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 | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 14 | Day |
Last modified on
| 2018 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036121
