UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046097 |
|---|---|
| Receipt number | R000052590 |
| Scientific Title | The retrospective study on antioxidant components and fertility |
| Date of disclosure of the study information | 2021/11/19 |
| Last modified on | 2023/11/20 09:24:01 |
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Basic information
Public title
The retrospective study on antioxidant components and fertility
Acronym
The retrospective study on antioxidant components and fertility
Scientific Title
The retrospective study on antioxidant components and fertility
Scientific Title:Acronym
The retrospective study on antioxidant components and fertility
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively examine the effect of taking antioxidant components on assisted reproductive technology (ART) outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of oocytes retrieved, fertility rate, number of cleavage-stage embryos
Key secondary outcomes
serum hormone level (FSH, LH, E2, P, AMH) and OHSS incidence
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Those who attended the practice and purchased the food containing antioxidant ingredients from September 2020 to February 2021.
2) Those who received assisted reproductive technology (ART) treatment before and after the purchase.
Key exclusion criteria
1) Those who are found not to be using the food containing antioxidant ingredients.
2) Those who are judged by the principal investigator to be inappropriate for research.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tetsunori |
| Middle name | |
| Last name | Mukaida |
Organization
Hiroshima HART Clinic
Division name
Director of the hospital
Zip code
732-0822
Address
3-1-301 Matsubara-cho, Minami-ku Hiroshima, 732-0822
TEL
082-567-3866
info@hiroshima-hart.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Shidomi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science Business Plannning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo, 105-0022
TEL
03-6832-6013
Homepage URL
shidomi@rohto.co.jp
Sponsor or person
Institute
Hiroshima HART Clinic
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
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
SOUKEN Co., Ltd
Address
3 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105
Tel
03-5408-1555
y_huzita@mail.souken-r.com
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 19 | 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
31
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
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the effects of antioxidants on fertility by comparing the results before and after intake.
Management information
Registered date
| 2021 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052590
