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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030493
Receipt No. R000034811
Scientific Title Clinical study of infertility treatment using platelet rich plasma (PRP) to endometrium.
Date of disclosure of the study information 2017/12/25
Last modified on 2019/04/05

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Basic information
Public title Clinical study of infertility treatment using platelet rich plasma (PRP) to endometrium.
Acronym Clinical study of infertility treatment using platelet rich plasma (PRP) to endometrium.
Scientific Title Clinical study of infertility treatment using platelet rich plasma (PRP) to endometrium.
Scientific Title:Acronym Clinical study of infertility treatment using platelet rich plasma (PRP) to endometrium.
Region
Japan

Condition
Condition Sterility
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Object to confirm the effect and the safety exerted on endometrium by inculcation in the uterus of platelet rich plasma in a patient during infertility treatment and consider the implantation rate preliminary.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Thickness of the endometrium
Key secondary outcomes Safety
Implantation rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 PRP Injection into uterus
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria (1) The female patient who is undergoing infertility treatment, receives in vitro fertilization (IVF) or Intracyteplasmic sperm injection (ICSI) and schedules frozen embryo transplanting (FET) of the hormone replacement cycle.
(2) The thickness of the endometrium is less than 7 mm.
(3) Obtain informed consent from patient herself.
(4) Age over 18 and under 50 (Freeze embryo until 42 years old)
Key exclusion criteria (1) Patient with liver dysfunction
(2) Hb less than 11g/dL
(3) Platelet less than 150,000/mm3
(4) Patient using anticoagulation medicine.
(5) Pregnant
(6) Additionally something a study doctor in attendance judges to be unsuitable as a target of this research
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Tsutsumi, M.D., Ph.D.
Organization Sanno Hospital
Division name Reproduction Center
Zip code
Address 8-10-16 Akasaka, Minato-ku, Tokyo
TEL +81-3-3402-3151
Email osamut@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Maki Kusumi, M.D., Ph.D.
Organization Sanno Hospital
Division name Reproduction Center
Zip code
Address 8-10-16 Akasaka, Minato-ku, Tokyo
TEL +81-3-3402-3151
Homepage URL
Email sannordc@gmail.com

Sponsor
Institute CONCIDE(Correct health Information for Cooperative and innovative development of society)
Institute
Department

Funding Source
Organization Aeon International Inc.
Organization
Division
Category of Funding Organization Profit 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 山王病院(東京都)
Sanno Hospital (TOKYO)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 25 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 Completed
Date of protocol fixation
2018 Year 02 Month 14 Day
Date of IRB
2017 Year 12 Month 13 Day
Anticipated trial start date
2018 Year 02 Month 19 Day
Last follow-up date
2019 Year 01 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 20 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034811

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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