UMIN-CTR Clinical Trial

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 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
Email	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
Email	funabiki_m@oakclinic-group.com

Sponsor
Institute	Oak Clinic, Japan
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029541