UMIN-CTR Clinical Trial

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	Obsterics 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
Last 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
Email	kamiya@fine.ocn.ne.jp

Public contact
1st 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
Email	mihok@lemon.plala.or.jp

Sponsor
Institute	Kamiya Ladies Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041497