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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006536
Receipt No. 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 2018/03/26

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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
Obsterics 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 No treatment
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
Middle name
Last name Yoshitaka Nakamura
Organization Oak Clinic
Division name IVF Center
Zip code
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
Middle name
Last name Kotaro Kitaya
Organization Oak Clinic
Division name IVF Center
Zip code
Address 06-4398-1000
TEL 0643981000
Homepage URL
Email kitaya_k@oakclinic-group.com

Sponsor
Institute Oak Clinic
Institute
Department

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 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
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.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


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