UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051114 |
|---|---|
| Receipt number | R000058297 |
| Scientific Title | Intrauterine injection of stem cells from human exfoliated deciduous teeth derived conditioned medium (SHED-CM) for recurrent implantation failure |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/05/21 13:43:56 |
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Basic information
Public title
Intrauterine injection of stem cells from human exfoliated deciduous teeth derived conditioned medium (SHED-CM) for recurrent implantation failure
Acronym
Intrauterine injection of stem cells from human exfoliated deciduous teeth derived conditioned medium (SHED-CM) for recurrent implantation failure
Scientific Title
Intrauterine injection of stem cells from human exfoliated deciduous teeth derived conditioned medium (SHED-CM) for recurrent implantation failure
Scientific Title:Acronym
Intrauterine injection of stem cells from human exfoliated deciduous teeth derived conditioned medium (SHED-CM) for recurrent implantation failure
Region
| Japan |
Condition
Condition
implantation failure
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to retrospectively examine whether intrauterine injection of stem cells from human exfoliated deciduous teeth derived conditioned medium (SHED-CM) in patients with endometrial thinning and recurrent implantation failure affect reproductive outcomes and verify its safety and efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical pregnancy rate per embryo transfer cycle
Key secondary outcomes
Endometrial thickness at the time of embryo transfer, miscarriage rate, and live birth rate.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with recurrent implantation failure in whom pregnancy is not obtained after 3 or more embryo transfers or patients with endometrial thinning (<7mm)
Key exclusion criteria
Those who have not been treated for chronic endometritis
Those who are undergoing treatment for viral infections
People who are allergic to penicillin, aminoglycoside, or macrolide antibiotics, or who have a history of them
People with malignant tumors currently under treatment
Persons subject to doping tests
Those who are judged to be inappropriate for use by a doctor
Persons who cannot obtain consent to the product specifications for any reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproduction Clinic Osaka
Zip code
530-0011
Address
4-20, Ofuka-cho, Kita-Ku, Osaka, Japan
TEL
06-6136-3344
tishikawa@reposaka.jp
Public contact
Name of contact person
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproduction Clinic Osaka
Zip code
530-0011
Address
4-20, Ofuka-cho, Kita-Ku, Osaka, Japan
TEL
06-6136-3344
Homepage URL
tishikawa@reposaka.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Reproduction Clinic Osaka
Address
4-20, Ofuka-cho, Kita-Ku, Osaka, Japan
Tel
06-6136-3344
ssumori@reposaka.jp
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
| 2024 | Year | 06 | Month | 01 | 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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The endometrial thickness, clinical pregnancy rate, miscarriage rate, live birth rate, and the occurrence of adverse events in the embryo transfer cycle in which SHED-CM injection was performed.
Management information
Registered date
| 2023 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058297
