UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038582
Receipt number R000043939
Scientific Title Examination of therapeutic effects of intrauterine microbiota by antibiotics, Probiotics and Prebiotics
Date of disclosure of the study information 2019/11/14
Last modified on 2021/08/03 11:59:56

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Basic information

Public title

Establishment of treatment method for intrauterine microbiota

Acronym

Establishment of treatment method for intrauterine microbiota

Scientific Title

Examination of therapeutic effects of intrauterine microbiota by antibiotics, Probiotics and Prebiotics

Scientific Title:Acronym

Examination of therapeutic effects of intrauterine microbiota by antibiotics, Probiotics and Prebiotics

Region

Japan


Condition

Condition

Intrauterine microbiota abnormalities

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Establishment of treatment for Intrauterine microbiota abnormalities

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percentage of Lactobacillus and Bifidobacterium in Intrauterine microbiota

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Probiotics(oral medicine 3g/day)30days
Prebiotics(oral medicine 300mg/day)30days

Interventions/Control_2

antibiotics(oral medicine 750mg/day)7days
antibiotics(Vaginal tablet 250mg)1 time

Interventions/Control_3

Probiotics(oral medicine 3g/day)30days
Prebiotics(oral medicine 300mg/day)30days
antibiotics(oral medicine 750mg/day)7days
antibiotics(Vaginal tablet 250mg)1 time

Interventions/Control_4

Probiotics(oral medicine 3g/day)30days
Prebiotics(oral medicine 600mg/day)30days
antibiotics(oral medicine 750mg/day)7days
antibiotics(Vaginal tablet 250mg/day)7days

Interventions/Control_5

Probiotics(Vaginal tablet 1cap/day)7days

Interventions/Control_6

Probiotics(Vaginal tablet 1cap/day)7days
antibiotics(oral medicine 750mg/day)7days
antibiotics(Vaginal tablet 250mg/day)7days

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

Repeated implantation failure
Less than 90% of Lactobacillus or Bifidobacterium in the uterine microbiota

Key exclusion criteria

History of uterine surgery

Target sample size

95


Research contact person

Name of lead principal investigator

1st name DAISUKE
Middle name
Last name KADOGAMI

Organization

IVF Namba Clinic

Division name

Doctor

Zip code

5500015

Address

Osaka-shi,Nishi-Ku,Minamihorie,1-17-28

TEL

0665348824

Email

kadogami515@ivfjapan.com


Public contact

Name of contact person

1st name DAISUKE
Middle name
Last name KADOGAMI

Organization

IVF Namba Clinic

Division name

Doctor

Zip code

5500015

Address

Osaka-shi,Nishi-Ku,Minamihorie,1-17-28

TEL

0665348824

Homepage URL


Email

kadogami515@ivfjapan.com


Sponsor or person

Institute

IVF Namba Clinic

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

IVF Japan

Address

Higashioosaka-shi,Nagatahigasi,1-1-14

Tel

0643088824

Email

hirota@ivfoosaka.com


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 11 Month 14 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

Enrolling by invitation

Date of protocol fixation

2019 Year 11 Month 14 Day

Date of IRB

2018 Year 11 Month 19 Day

Anticipated trial start date

2019 Year 11 Month 14 Day

Last follow-up date

2022 Year 12 Month 20 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 11 Month 14 Day

Last modified on

2021 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043939


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name