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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name