UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030493 |
|---|---|
| Receipt number | 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 11:32:00 |
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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
| Obstetrics 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
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
sannordc@gmail.com
Sponsor or person
Institute
CONCIDE(Correct health Information for Cooperative and innovative development of society)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034811
