UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006536
Receipt number R000007746
Scientific Title Effect of Antibiotic Therapy on Reproductive Outcome in Infertile Patients with Repeated Embryo Implantation Failures and Chronic Endometritis
Date of disclosure of the study information 2011/10/13
Last modified on 2022/09/15 17:27:13

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Basic information

Public title

Effect of Antibiotic Therapy on Reproductive Outcome in Infertile Patients with Repeated Embryo Implantation Failures and Chronic Endometritis

Acronym

Effect of Antibiotic Therapy on Reproductive Outcome in Infertile Patients with Repeated Embryo Implantation Failures and Chronic Endometritis

Scientific Title

Effect of Antibiotic Therapy on Reproductive Outcome in Infertile Patients with Repeated Embryo Implantation Failures and Chronic Endometritis

Scientific Title:Acronym

Effect of Antibiotic Therapy on Reproductive Outcome in Infertile Patients with Repeated Embryo Implantation Failures and Chronic Endometritis

Region

Japan


Condition

Condition

Chronic Endometritis

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify if antibiotic therapy for chronic endometritis improves reproductive outcome in infertile patients with a history of three or more consecutive implantation failures after in vitro fertilization and embryo transfer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Implantation rate and clinical pregnancy rate

Key secondary outcomes

Ongoing pregnancy rate and biochemical pregnancy rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral administration of 200mg doxycycline (100mg tablet, twice a day) for 14 days

Interventions/Control_2


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 with present illness of chronic endometritis and history of three or more consecutive implantation failures after in vitro fertilization and embryo transfer.
Provided written informed consent

Key exclusion criteria

Patients with a history of hyper-sensitivity to doxycycline

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshitaka
Middle name
Last name Nakamura

Organization

Oak Clinic

Division name

IVF Center

Zip code

5570045

Address

2-7-9 Tamade-nishi, Nishinari, Osaka, JAPAN

TEL

06-4398-1000

Email

nakamura_y@oakclinic-group.com


Public contact

Name of contact person

1st name Kotaro
Middle name
Last name Kitaya

Organization

Oak Clinic

Division name

IVF Center

Zip code

5570045

Address

06-4398-1000

TEL

0643981000

Homepage URL


Email

kitaya_k@oakclinic-group.com


Sponsor or person

Institute

Oak 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

Oak Clinic

Address

2-7-9 Tamade-Nishi, Nishinari-ku, Osaka, Japan

Tel

0643981000

Email

kitaya_k@oakclinic-group.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

医療法人オーク会


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 13 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2011 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date

2014 Year 06 Month 30 Day

Date of closure to data entry

2014 Year 07 Month 15 Day

Date trial data considered complete

2017 Year 03 Month 15 Day

Date analysis concluded

2017 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2011 Year 10 Month 13 Day

Last modified on

2022 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007746


Research Plan
Registered date File name
2017/10/05 UMIN000006536.doc

Research case data specifications
Registered date File name
2017/10/05 UMIN000006536.doc

Research case data
Registered date File name
2017/10/05 UMIN000006536.doc