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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041497


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name