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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043812
Receipt No. R000050010
Scientific Title Usefulness of PFC-FD in cases of implantation failure associated with endometrial thinning
Date of disclosure of the study information 2021/04/05
Last modified on 2021/04/01

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Basic information
Public title Usefulness of PFC-FD in cases of implantation failure associated with endometrial thinning
Acronym Study on the usefulness of PFC-FD
Scientific Title Usefulness of PFC-FD in cases of implantation failure associated with endometrial thinning
Scientific Title:Acronym Study on the usefulness of PFC-FD
Region
Japan

Condition
Condition endometrial thinning,recurret implantation failure
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effecttive of uterine infusion of PFC-FD on endometrial thinning,recurret implantation failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pregnancy rate
Key secondary outcomes Endometrial thickness, fertility rate, and abortion 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
Other
Interventions/Control_1 Intra-uterine injection of PFC-FD
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
50 years-old >
Gender Female
Key inclusion criteria mplantation failure more than three times,
less than 8.0 mm of endometrium at the time of implantation
Key exclusion criteria autoimmune disorders, sexually transmitted diseases, infectious diseases,
tubal factor infertility/tubal obstruction, chronic inflammatory diseases, endometriosis, chronic
endometritis, and endocrine disorders such as thyroid dysfunction,were excluded in general.
Body Mass Index (BMI) above 30 or less than 18.5, hypothalamic-pituitary disorders
Target sample size 100

Research contact person
Name of lead principal investigator
1st name DAISUKE
Middle name
Last name KADOGAMI
Organization IVF Namba Clinic
Division name medical office
Zip code 5500015
Address 1-17-28 Minamihorie Nishi-ku Osaka JAPAN
TEL 09014417520
Email kadogami515@ivfjapan.com

Public contact
Name of contact person
1st name DAISUKE
Middle name
Last name KADOGAMI
Organization IVF Namba Clinic
Division name Doctor
Zip code 5500015
Address 1-17-28 Minamihorie Nishi-ku Osaka JAPAN
TEL 09014417520
Homepage URL
Email kadogami515@ivfjapan.com

Sponsor
Institute IVF Namba Clinic
Institute
Department

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 IVF JAPAN
Address 1-17-28 Minamihorie Nishi-ku Osaka JAPAN
Tel 09014417520
Email kadogami515@ivfjapan.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
2021 Year 04 Month 05 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 12 Day
Last follow-up date
2021 Year 04 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 01 Day
Last modified on
2021 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050010

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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