UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017758 |
|---|---|
| Receipt number | 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 14:09:30 |
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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
| Obstetrics 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
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
mjinno@s9.dion.ne.jp
Sponsor or person
Institute
Women's Clinic Jinno
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020569
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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