UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053739 |
|---|---|
| Receipt number | R000061327 |
| Scientific Title | Clinical study of ART-A & -SR for patient with recurrent IVF failure, repeated pregnancy losses, and patient who has chromosomal structural rearrangement. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/02/29 18:11:26 |
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Basic information
Public title
Clinical study of ART-A & -SR for patient with recurrent IVF failure, repeated pregnancy losses, and patient who has chromosomal structural rearrangement.
Acronym
Clinical study of ART-A & -SR
Scientific Title
Clinical study of ART-A & -SR for patient with recurrent IVF failure, repeated pregnancy losses, and patient who has chromosomal structural rearrangement.
Scientific Title:Acronym
Clinical study of ART-A & -SR
Region
| Japan |
Condition
Condition
repeated ART failure, repeated miscarriage and chromosomal structural rearrangement
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy of PGT-A & -STR for patient with recurrent IVF failure, repeated pregnancy losses, and patient who has chromosomal structural rearrangement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
on-going pregnancy rate at 12th WGA
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
PGT-A&-SR
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
| 43 | years-old | > |
Gender
Female
Key inclusion criteria
Recurrent IVF failure
Recurrent pregnancy losses
Chromosomal structural rearrangement
Key exclusion criteria
For PGT-A, patient who has chromosomal structural rearrangement is excluded.
For PGT-SR, patient who has no chromosomal structural rearrangement is excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
Tohoku university hospital
Division name
Department of obstetrics and gynecology
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177254
masahito.tachibana.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
Tohoku university hospital
Division name
Department of obstetrics and gynecology
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177254
Homepage URL
masahito.tachibana.c1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
NA
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
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryomachi, Aoba-ward,
Tel
227177254
ec@rinri.hosp.tohoku.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
| 2024 | Year | 04 | 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
| 2024 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061327
