UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025679 |
|---|---|
| Receipt number | R000029541 |
| Scientific Title | The evaluation for IFCR <intrauterine fiberscope and curettage of the endometrium> by a prospective randomized controlled trial |
| Date of disclosure of the study information | 2017/01/16 |
| Last modified on | 2021/05/02 22:42:22 |
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Basic information
Public title
The evaluation for IFCR <intrauterine fiberscope and curettage of the endometrium> by a prospective randomized controlled trial
Acronym
The evaluation for IFCE by RCT
Scientific Title
The evaluation for IFCR <intrauterine fiberscope and curettage of the endometrium> by a prospective randomized controlled trial
Scientific Title:Acronym
The evaluation for IFCE by RCT
Region
| Japan |
Condition
Condition
Infertile patients with repeated embryo implantation failure
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does our technique with intrauterine fiberscope and curettage of the endometrium (IFCE) improves reproductive outcome for infertile patients with repeated embryo implantation failure ?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical pregnancy rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
IFCE group
Interventions/Control_2
non-IFCE group
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.
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.
5. 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
500
Research contact person
Name of lead principal investigator
| 1st name | Miyako |
| Middle name | |
| Last name | Funabiki |
Organization
Oak Clinic, Japan
Division name
IVF Center
Zip code
557-0045
Address
2-7-9 Tamade-nishi, Nishinari, Osaka, JAPAN
TEL
06-4398-1000
funabiki_m@oakclinic-group.com
Public contact
Name of contact person
| 1st name | Miyako |
| Middle name | |
| Last name | Funabiki |
Organization
Oak Clinic, Japan
Division name
IVF Center
Zip code
557-0045
Address
2-7-9 Tamade-nishi, Nishinari, Osaka, Japan
TEL
06-4398-1000
Homepage URL
funabiki_m@oakclinic-group.com
Sponsor or person
Institute
Oak Clinic, Japan
Institute
Department
Personal name
Funding Source
Organization
Oak Clinic, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oak Clinic Sumiyoshi, Japan
Address
2-7-9, Tamadenishi, Nishinari-ku, Osaka-city, Japan
Tel
0643981019
oakclinic.irb@gmail.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 16 | 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
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | 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
| 2017 | Year | 01 | Month | 14 | Day |
Last modified on
| 2021 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029541
