UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	at-fukui@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044421