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
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
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
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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/7746
