UMIN-CTR Clinical Trial

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
Last 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
1st 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