UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060650 |
|---|---|
| Receipt number | R000069293 |
| Scientific Title | Impact of Luteinizing Hormone (LH) Supplementation in Ovarian Stimulation Protocols Stratified by Age and AMH on Euploid Embryo Count and Cumulative Live Birth Rate in Preimplantation Genetic Testing: A Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/02/15 |
| Last modified on | 2026/02/11 21:03:23 |
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Basic information
Public title
A Retrospective Cohort Study on the Impact of Age-Stratified Optimal Ovarian Stimulation Regimens on Euploid Embryo Yield and Pregnancy Outcomes in Preimplantation Genetic Testing for Aneuploidy (PGT-A)
Acronym
Age-Stratified Ovarian Stimulation and PGT-A Outcomes Study
Scientific Title
Impact of Luteinizing Hormone (LH) Supplementation in Ovarian Stimulation Protocols Stratified by Age and AMH on Euploid Embryo Count and Cumulative Live Birth Rate in Preimplantation Genetic Testing: A Retrospective Cohort Study
Scientific Title:Acronym
LH Supplementation and PGT-A Outcomes: A Stratified Analysis
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the optimal ovarian stimulation regimen (total FSH/LH dose, use of ovulation induction drugs, etc.) for each age group in infertile patients undergoing PGT-A, and to establish a treatment strategy to maximize the rate of normal embryo acquisition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Euploid or mosaic embryo count, cumulative live birth rate
Key secondary outcomes
Clinical pregnancy rate, live birth rate, miscarriage rate, number of eggs collected, number of mature eggs, blastocyst formation rate
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
- Subjects who have provided written consent to participate in this study
- Infertility patients who underwent PGT-A and underwent egg retrieval between August 1, 2020 and December 31, 2023
Key exclusion criteria
- Individuals who are unable to give consent
- Individuals who are otherwise deemed inappropriate by the principal investigator or co-researcher
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproductive medicine
Zip code
530-0011
Address
4-20, Ofuka-cho, Kita-Ku, Osaka, Japan
TEL
06-6136-3344
yohara@reposaka.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Sumori |
Organization
Reproduction Clinic Osaka
Division name
General Affairs Department
Zip code
530-0011
Address
4-20, Ofuka-cho, Kita-Ku, Osaka, Japan
TEL
06-6136-3344
Homepage URL
ssumori@reposaka.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
Institute
Department
Personal name
Funding Source
Organization
Reproduction Clinic Osaka
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reproduction Clinic Osaka Ethics Review Committee
Address
4-20, Ofuka-cho, Kita-Ku, Osaka, Japan
Tel
06-6136-3344
yohara@reposaka.jp
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 | 02 | Month | 15 | 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
| 2026 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be collected retrospectively from electronic medical records, and the relationship between ovarian stimulation regimens, number of normal embryos, and pregnancy prognosis will be analyzed by age group using multivariate analysis.
Management information
Registered date
| 2026 | Year | 02 | Month | 11 | Day |
Last modified on
| 2026 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069293
