UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043812 |
|---|---|
| Receipt number | 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 | 2023/10/02 11:55:12 |
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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
| Obstetrics 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
0665348824
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
0665348824
Homepage URL
kadogami515@ivfjapan.com
Sponsor or person
Institute
IVF Namba Clinic
Institute
Department
Personal name
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
0665348824
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 21 | Day |
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
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050010
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
