UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034994 |
|---|---|
| Receipt number | R000039907 |
| Scientific Title | A prospective study for IFCR <intrauterine fiberscope and curettage of the endometrium> for patients with RIF |
| Date of disclosure of the study information | 2018/11/26 |
| Last modified on | 2018/11/26 12:12:20 |
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Basic information
Public title
A prospective study for IFCR <intrauterine fiberscope and curettage of the endometrium> for patients with RIF
Acronym
A prospective study for IFCR for patients with RIF
Scientific Title
A prospective study for IFCR <intrauterine fiberscope and curettage of the endometrium> for patients with RIF
Scientific Title:Acronym
A prospective study for IFCR for patients with RIF
Region
| Japan |
Condition
Condition
Infertile patients with RIF
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The change of clinical pregnancy rates for thepatients with RIF before and after IFCE.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical pregnancy rates
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
IFCE group
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Infertile patients with repeated embryo implantation failure (RIF).
2. Patients indicated to undergo a cycle of IVF/ICSI with their own oocytes.
3. Age <= 50 years.
4. BMI: 18.5 to 30.
5. Normal ovarian reserve (AFC >= 8; FSH < 8).
6. The most appropriate stimulation protocol will be decided by their doctor.
Key exclusion criteria
1. Patients with a severe male factor (spermatozoa < 2 million/ml).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyako Funabiki |
Organization
Oak Clinic
Division name
IVF Center
Zip code
Address
Osaka
TEL
0666537080
funabiki_m@oakclinic-group.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyako Funabiki |
Organization
Oak Clinic
Division name
IVF Center
Zip code
Address
Osaka
TEL
0666537080
Homepage URL
funabiki_m@oakclinic-group.com
Sponsor or person
Institute
Oak Clinic
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Oak Clinic
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 11 | Month | 26 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 26 | Day |
Last modified on
| 2018 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039907
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| Registered date | File name |
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| Registered date | File name |
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