UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005830 |
|---|---|
| Receipt number | R000006890 |
| Scientific Title | G-CSF therapy for unexplained recurrent miscarriage |
| Date of disclosure of the study information | 2011/06/22 |
| Last modified on | 2016/06/24 16:22:34 |
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Basic information
Public title
G-CSF therapy for unexplained recurrent miscarriage
Acronym
G-CSF therapy for unexplained recurrent miscarriage
Scientific Title
G-CSF therapy for unexplained recurrent miscarriage
Scientific Title:Acronym
G-CSF therapy for unexplained recurrent miscarriage
Region
| Japan |
Condition
Condition
Unexplained recurrent miscarriage
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of G-CSF therapy in unexplained recurrent miscarriage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
To compare the obstetrical outcome; the rate of live birth and spontaneous abortion, between G-CSF and placebo group in the intrauterine pregnancy
Key secondary outcomes
To evaluate the maternal side effects and the long term safety of children till six years
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lenograstim, genetical recombination, granulocyte colony stimulating factor
Interventions/Control_2
placebo (saline)
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1) no medical complication
2) no previous child-birth
3) experienced four or more consecutive spontaneous early miscarriages except chemical abortion
4) unexplained reason with detail examination of recurrent pregnancy loss
Key exclusion criteria
history of allergy to G-CSF
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kinue Katano |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku, Nagoya
TEL
052-853-8241
og.kktn@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kinue Katano |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku, Nagoya
TEL
052-853-8241
Homepage URL
og.kktn@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
名古屋市立大学病院（愛知県）Nagoya City University Hospital (Aichi)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 22 | Day |
Last modified on
| 2016 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006890
