UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038952 |
|---|---|
| Receipt number | R000044421 |
| Scientific Title | Intravenous immunoglobulin or intralipid treatment for recurrent pregnancy loss or implantation failures women with NK cell abnormality |
| Date of disclosure of the study information | 2019/12/24 |
| Last modified on | 2019/12/22 22:58:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Intravenous immunoglobulin or intralipid treatment for recurrent pregnancy loss or implantation failures women with NK cell abnormality
Acronym
IVIG or intralipid treatment for RPL or IF women with NK cell abnormality
Scientific Title
Intravenous immunoglobulin or intralipid treatment for recurrent pregnancy loss or implantation failures women with NK cell abnormality
Scientific Title:Acronym
IVIG or intralipid treatment for RPL or IF women with NK cell abnormality
Region
| Japan |
Condition
Condition
Recurrent pregnancy loss, implantation failure
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of intravenous immunoglobulin or intralipid for women with recurrent pregnancy loss or implantation failure with NK cell abnormality
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For recurrent pregnancy loss women with NK cell abnormality: ongoing pregnancy rate at 22 weeks of pregnancy
For implantation failure women with NK cell abnormality: pregnancy rate and ongoing pregnancy rate at 22 weeks of pregnancy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
IVIG: every 4 weeks
Interventions/Control_2
Intralipid: every 2 to 4 weeks
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
RPL or IF women with NK cell abnormality
Key exclusion criteria
Untreated other causes of infertility or RPL
Allergy for IVIG or intralipid
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Fukkui |
Organization
Hyogo College of Medicine
Division name
Obstetrics and Gynecology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6481
at-fukui@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Fukui |
Organization
Hyogo College of Medicine
Division name
Obstetrics and Gynecology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6481
Homepage URL
at-fukui@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
IRB, Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.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
| 2019 | Year | 12 | Month | 24 | 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
| 2017 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 22 | Day |
Last modified on
| 2019 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044421
