UMIN-CTR Clinical Trial

Basic information
Public title	A prospective, randomized study to examine whether administration of plant extract improves outcomes of assisted reproductive technology (ART) therapy.
Acronym	Examination of effectiveness of plant extract on assisted reproductive technology (ART) therapy.
Scientific Title	A prospective, randomized study to examine whether administration of plant extract improves outcomes of assisted reproductive technology (ART) therapy.
Scientific Title:Acronym	Examination of effectiveness of plant extract on assisted reproductive technology (ART) therapy.
Region	Japan

Condition
Condition	Infertility of high age treated by assisted reproductive technology (ART) therapy.
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine whether outcomes of assisted reproductive technology (ART) therapy are improved by administration of plant extract, which suppresses production of advanced glycation end-products in vitro.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The number of superior embryos.
Key secondary outcomes	Follicular growth, the numbers of retrieved oocytes, fertilized oocytes and embryos, pregnancy rates, and the changes in various metabolic and hormonal examinations.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	Food
Interventions/Control_1	ART patients who meet inclusion criteria and do not meet exclusion criteria are prospectively allocated at random into two groups as follows; the control group who undergoes ART therapy without administration of plant extract, and the plant-extract group who undergoes ART therapy after one to two months of administration of plant extract. And the outcomes of ART are compared between two groups. In the plant-extract group, patients begins daily administration (once just before breakfast) of plant extract, 100 mg (Hayashikane Sangyou Co.,Ltd) on the menstrual cycle day 2-4 after they receive various clinical examinations as follows; glucometabolism ex. (oral glucose tolerance test, C-peptide, Hb A1c, glycoalbumin, general chemistry, etc.), hormones (FSH, LH, E2, PRL, AMH, T, DHEA-S, etc.), measurements of blood advanced glycation end-products (AGEs), and skin test (Cutometer ex., questionnaire on skin conditions, etc.). After 1-2 months of administration of plant extract, they repeat the same examinations and then undergo ART therapy. Follicular fluid are collected at oocyte retrieval and AGEs in the fluid are measured. Patients can freely decide to participate in the trial or not, and do not have any disadvantages when they do not participate. Informed consents are obtained from all participants after they have received appropriate explanations about implications, purposes, methods, expected benefits, and possible risks of plant extract administration, and the protection of privacy.
Interventions/Control_2	The control group undergoes ART therapy without administration of plant extract. The same examinations as described above in the plant-extract group are received on cycle day 2-4 before 1-2 months of and just before ART therapy. AGEs in follicular fluid are also measured.
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	38 years-old <=
Age-upper limit	42 years-old >=
Gender	Female
Key inclusion criteria	The study includes patients who satisfy all the following criteria; (1) 38-42 years of age, (2) to undergo the first, second or third attempt of assisted reproductive technology (ART) therapy, (3) no medication to affect the glucometabolism is nor has been administered.
Key exclusion criteria	Patients are excluded when they meet any of the following criteria; (1) definitely diagnosed diabetes mellitus, (2) organic uterine infertility (uterine anormaly, Asherman syndrome, etc.), (3) non-obstructive azoospermia.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masao Jinno
Organization	Women's Clinic Jinno
Division name	Reproductive Medicine
Zip code
Address	3-1-39-201 Kokuryou-chou, Choufu City, Tokyo, Japan
TEL	042-480-3105
Email	mjinno@s9.dion.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Masao Jinno
Organization	Women's Clinic Jinno
Division name	Reproductive Medicine
Zip code
Address	3-1-39-201 Kokuryou-chou, Choufu City, Tokyo, Japan
TEL	042-480-3105
Homepage URL
Email	mjinno@s9.dion.ne.jp

Sponsor
Institute	Women's Clinic Jinno
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shoko Takeshita, Tomohiro Uemura, Michio Yamada: Research & Development Division, Hayashikane Sangyo Co.,Lid.
Name of secondary funder(s)	Shoko Takeshita, Tomohiro Uemura, Michio Yamada: Research & Development Division, Hayashikane Sangyo Co.,Lid.

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	ウィメンズクリニック神野（東京都）/ Women's Clinic Jinno (Tokyo)

Other administrative information
Date of disclosure of the study information	2015 Year 06 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	Open public recruiting
Date of protocol fixation	2015 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date	2015 Year 06 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	2015 Year 06 Month 01 Day
Last modified on	2015 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020569

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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