UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061986 |
|---|---|
| Receipt number | R000070863 |
| Scientific Title | Effects of Kinmemai Consumption on ART Outcomes and Glycation Stress Markers |
| Date of disclosure of the study information | 2026/06/25 |
| Last modified on | 2026/06/20 12:45:27 |
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Basic information
Public title
Study of the Effects of Kinmemai Consumption on ART Outcomes
Acronym
Study of the Effects of Kinmemai Consumption on ART Outcomes
Scientific Title
Effects of Kinmemai Consumption on ART Outcomes and Glycation Stress Markers
Scientific Title:Acronym
Effects of Kinmemai Consumption on ART Outcomes and Glycation Stress Markers
Region
| Japan |
Condition
Condition
Primary infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of continuous Kinmemai consumption on ART outcomes, including clinical pregnancy and live birth rates, in patients undergoing assisted reproductive technology (ART). In addition, glycation stress markers in follicular fluid and seminal plasma will be assessed to investigate their associations with ART outcomes and to explore potential underlying mechanisms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical pregnancy rate following the first frozen-thawed embryo transfer.
Clinical pregnancy is defined as the presence of at least one intrauterine gestational sac confirmed by transvaginal ultrasonography.
Assessment time point: At the time of gestational sac confirmation following the first frozen-thawed embryo transfer.
Key secondary outcomes
1. Live birth rate.
Live birth is defined as the delivery of at least one live-born infant after 22 weeks of gestation.
Assessment time point: At delivery.
2. Miscarriage rate.
Miscarriage is defined as spontaneous pregnancy loss after confirmation of a clinical pregnancy and before 22 weeks of gestation.
Assessment time point: During pregnancy follow-up until delivery.
3. Blastocyst formation rate.
Blastocyst formation rate is defined as the proportion of embryos developing to the blastocyst stage among normally fertilized oocytes.
Assessment time point: During the embryo culture period.
4. Correlation between glycation stress markers and ART outcomes.
Associations between glycation stress markers measured in follicular fluid and seminal plasma and ART outcomes, including clinical pregnancy, live birth, miscarriage, and blastocyst formation, will be evaluated.
Assessment time point: At completion of ART treatment and outcome assessment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will consume Kinmemai as their staple food throughout the study period.
Female participants will consume Kinmemai at least twice daily, and male participants at least once daily.
Consumption will begin at least one month before the initiation of ART treatment and will continue until the first frozen-thawed embryo transfer. Participants who achieve pregnancy following the first frozen-thawed embryo transfer will continue Kinmemai consumption until delivery.
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1. No previous ART treatment
2. Female age <40 years
3. Nulliparous women
4. Male age <50 years
5. Anti-Mullerian Hormone (AMH) at least 1.0 ng/mL
Key exclusion criteria
1. Serious organic disease
2. Active medical illness
3. Inability to provide informed consent
4. Considered unsuitable by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Morimoto |
Organization
HORAC Grand Front Osaka Clinic
Division name
Department of Reproductive Medicine
Zip code
5300011
Address
Grand Front Osaka Tower B 15F, 3-1 Ofukacho, Kita-ku, Osaka 530-0011, Japan
TEL
0663778824
wakikawa757@ivfjapan.com
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Wakikawa |
Organization
HORAC Grand Front Osaka Clinic
Division name
Department of Reproductive Medicine
Zip code
5300011
Address
Grand Front Osaka Tower B 15F, 3-1 Ofukacho, Kita-ku, Osaka 530-0011, Japan
TEL
0663778824
Homepage URL
wakikawa757@ivfjapan.com
Sponsor or person
Institute
HORAC Grand Front Osaka Clinic
Institute
Department
Personal name
Funding Source
Organization
Funding and material support:
Ishokudogen Crude Drug Research Foundation
Study food supply:
TOYO RICE Corporation (provider of Kinmemai)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sankeikai Medical Corporation Ethics Committee Office
Address
1-1-4 Nagatahigashi, Higashiosaka, Osaka 577-0012, Japan
Tel
0643088824
hirota@ivfosaka.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
| 2026 | Year | 06 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 20 | Day |
Last modified on
| 2026 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070863
