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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025679
Receipt No. 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 2017/01/14

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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
Obsterics 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
Middle name
Last name Miyako Funabiki
Organization Oak Clinic
Division name IVF Center
Zip code
Address 2-7-9 Tamade-nishi, Nishinari, Osaka, JAPAN
TEL 06-4398-1000
Email 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 2-7-9 Tamade-nishi, Nishinari, Osaka, JAPAN
TEL 06-4398-1000
Homepage URL
Email funabiki_m@oakclinic-group.com

Sponsor
Institute Oak Clinic
Institute
Department

Funding Source
Organization Oak Clinic
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
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

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
2017 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029541

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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