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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017758
Receipt No. R000020569
Scientific Title A prospective, randomized study to examine whether administration of plant extract improves outcomes of assisted reproductive technology (ART) therapy.
Date of disclosure of the study information 2015/06/01
Last modified on 2015/06/01

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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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