![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
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 |
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 |
|
Condition | ||
Condition | Infertility of high age treated by assisted reproductive technology (ART) therapy. | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |