UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036429 |
|---|---|
| Receipt number | R000041497 |
| Scientific Title | Randomized controlled trial of lactobacillus medications to treat bacterial vaginosis in infertility patients |
| Date of disclosure of the study information | 2019/04/06 |
| Last modified on | 2019/04/06 16:33:41 |
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Basic information
Public title
Randomized controlled trial of lactobacillus medications to treat bacterial vaginosis in infertility patients
Acronym
The trial of lactobacillus medication
Scientific Title
Randomized controlled trial of lactobacillus medications to treat bacterial vaginosis in infertility patients
Scientific Title:Acronym
The trial of lactobacillus medication
Region
| Japan |
Condition
Condition
bacterial vaginosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of lactobacillus mediation for the patients with bacterial vaginosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
The proportion of the improvement of Nugent score and the rate of increasing Lactobacillus in the patients' vagina
Key secondary outcomes
1, The proportion of patients experiencing improvement of the clinical pregnancy rate after treatment of lactobacillus medication
2, The proportion of patients experiencing improvement of the ongoing pregnancy rate after treatment of lactobacillus medication
3, The proportion of patients experiencing improvement of the miscarriage rate after treatment of lactobacillus medication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients who are diagnosed with bacterial vaginosis are treated with antibiotics. (Metronidazole or amoxicillin hydrate)
Interventions/Control_2
The patients with the results of the vaginal culture test are Nugent score 3 or more divide five kinds of groups,the patients of group A to D are treated with lactobacillus medication,the patients of groupE have no lactobacillus treatment.
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
1,The patients who voluntarily provide written informed consent to participate in the study
and comply with all study procedures
2, The patiens with general infertility
3, 45 years old or younger
4, The patients result of vaginal culture is Nugent score 3 or more
Key exclusion criteria
1)Pregnant woman
2)The patient who was not able to use the ethical drug by rule.
3)The patient with the underlying disease
4)The patient who is given a steroid and an immunosuppressive drug
5)The patient using a Intrauterine device.
6)The patient after using pill in a previous menstrual cycle.
7)Case with urinary tract infection.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hirobumi |
| Middle name | |
| Last name | Kamiya |
Organization
Kamiya Ladies Clinic
Division name
Reproductive Center
Zip code
060-0003
Address
Nittsu-Sapporo Bldg 2F 2-1 Nishi 2-chome Kita 3-Jo Chuo-ku, Sapporo 060-0003 Japan
TEL
011-231-2722
kamiya@fine.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Kawamata |
Organization
Kamiya Ladies Clinic
Division name
Reproductive Center
Zip code
060-0003
Address
Nittsu-Sapporo Bldg 2F 2-1 Nishi 2-chome Kita 3-Jo Chuo-ku, Sapporo 060-0003 Japan
TEL
011-231-2722
Homepage URL
mihok@lemon.plala.or.jp
Sponsor or person
Institute
Kamiya Ladies Clinic
Institute
Department
Personal name
Funding Source
Organization
no
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
Kamiya Ladies Clinic
Address
Nittsu-Sapporo Bldg 2F 2-1 Nishi 2-chome Kita 3-Jo Chuo-ku, Sapporo 060-0003 Japan
Tel
011-231-2722
kamiya@fine.ocn.ne.jp
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
| 2019 | Year | 04 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041497
