UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	G-CSF therapy for unexplained recurrent miscarriage
Title of the study (Brief title)	G-CSF therapy for unexplained recurrent miscarriage
Region	Japan

Condition
Condition	Unexplained recurrent miscarriage
Classification by specialty	Obsterics 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kinue Katano
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Obstetrics and Gynecology
Address	1 Kawasumi Mizuho-cho Mizuho-ku, Nagoya
TEL	052-853-8241
Email	og.kktn@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Kinue Katano
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Obstetrics and Gynecology
Address	1 Kawasumi Mizuho-cho Mizuho-ku, Nagoya
TEL	052-853-8241
Homepage URL
Email	og.kktn@med.nagoya-cu.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 10 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006890