UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022434 |
|---|---|
| Receipt number | R000025851 |
| Scientific Title | Intrauterine administration of autologous peripheral blood mononuclear cells in patients with repeated implantation failure. |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2023/11/29 09:49:03 |
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Basic information
Public title
Intrauterine administration of autologous peripheral blood mononuclear cells in patients with repeated implantation failure.
Acronym
Intrauterine administration of autologous PBMC in patients with RIF.
Scientific Title
Intrauterine administration of autologous peripheral blood mononuclear cells in patients with repeated implantation failure.
Scientific Title:Acronym
Intrauterine administration of autologous PBMC in patients with RIF.
Region
| Japan |
Condition
Condition
patients with repeated implantation failure
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the fertility rate improvement in the patient with repeated implantation failure by intrauterine administration of autologous PBMC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluations such as the grade of transplant embryo, the pregnancy rate and the delivery rate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Blood sampling and PBMC isolation on the day of oocyte retrieval.
Incubate PBMC for two days.
Fresh PBMC are obtained from the same patients 2 days after oocyte retrieval. After isolating PBMC, these fresh PBMCs were combined with 2 day cultured PBMC. Injection of the PBMC to the uterine cavity.
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
| 46 | years-old | >= |
Gender
Female
Key inclusion criteria
the patients with repeated implantation failure who performed embryo transfer more than 3times.
Key exclusion criteria
the patients whom an agreement is not obtained.
the patient deviated from 18y.o. to 46y.o.
the patient without the fertilized egg having good state.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mandai |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of obstetrics and gynecology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL
075-751-3269
mandai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Horie |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of obstetrics and gynecology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL
075-751-3269
Homepage URL
a_horie@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
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
Kyoto University Hospital / department of Ob & Gy
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto
Tel
075-751-3111
kuobgyn@kuhp.kyoto-u.ac.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
| 2016 | Year | 06 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025851
| Research Plan | |
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| 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 |
