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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006425
Receipt No. R000007624
Scientific Title Assisted reproductive technology (ART) for HIV discordant couples in which the male partner was HIV-positive and the female partner was negative
Date of disclosure of the study information 2011/11/01
Last modified on 2015/10/06

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Basic information
Public title Assisted reproductive technology (ART) for HIV discordant couples in which the male partner was HIV-positive and the female partner was negative
Acronym Assisted reproductive technology (ART) for HIV discordant couples in which the male partner was HIV-positive and the female partner was negative
Scientific Title Assisted reproductive technology (ART) for HIV discordant couples in which the male partner was HIV-positive and the female partner was negative
Scientific Title:Acronym Assisted reproductive technology (ART) for HIV discordant couples in which the male partner was HIV-positive and the female partner was negative
Region
Japan

Condition
Condition AIDS, sterility
Classification by specialty
Infectious disease Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to prevent HIV transmission from the HIV-positive male partner to the negative female partner by ART and to have children safety.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All female partners who underwent ART are tested for HIV antibodies and HIV RNA by real-time PCR.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 The spermatozoa are separated from semen samples by semen processing. After semen processing, the spermatozoa is tested for the presence of HIV by real-time PCR. The fertilized eggs are transferred after a negative result was obtained by real-time PCR in the culture medium of the fertilized eggs.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria HIV discordant couples in which the male partner is HIV-positive and the female partner is negative.
Key exclusion criteria Not married couples
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Tanaka
Organization Niigata University Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-757 Asahimachi-dori, chuo-ku, Niigata, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 377-2 Ohno-Higashi Osakasayama Osaka, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Obstetrics and Gynecology, Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization Sciences Research Grants
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 11 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 Terminated
Date of protocol fixation
2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 09 Month 28 Day
Last modified on
2015 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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