UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056349 |
|---|---|
| Receipt number | R000064381 |
| Scientific Title | Personalized embryo transfer timing based on endometrial receptivity analysis mitigates the negative impact of previous failed cycles in repeated implantation failure patients: A single-center retrospective cohort study |
| Date of disclosure of the study information | 2024/12/03 |
| Last modified on | 2024/12/03 22:53:17 |
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Basic information
Public title
Retrospective analysis of personalized embryo transfer timing based on endometrial receptivity testing in patients with implantation failure
Acronym
ERA-guided pET efficacy study
Scientific Title
Personalized embryo transfer timing based on endometrial receptivity analysis mitigates the negative impact of previous failed cycles in repeated implantation failure patients: A single-center retrospective cohort study
Scientific Title:Acronym
ERA-RIF study
Region
| Japan |
Condition
Condition
Repeated implantation failure (RIF) with no previous pregnancies after two or more embryo transfers
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether personalized embryo transfer timing based on endometrial receptivity analysis (ERA) could mitigate the negative impact of multiple previous failed cycles in patients with repeated implantation failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pregnancy rate (proportion of cases with blood hCG levels >100 mIU/mL confirmed four weeks after embryo transfer)
Key secondary outcomes
Ongoing pregnancy rate (proportion of cases with confirmed gestational sac and fetal heart beats by trans-vaginal ultrasound analysis after nine weeks of gestation)
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
No previous pregnancies
History of two or more failed ART cycles
Key exclusion criteria
Azoospermia
Known chromosomal abnormalities
Significant uterine abnormalities (fibroids or adenomyosis >5cm)
Endometrial thickness <7mm on the day of ET
Cases with only cleavage-stage embryos
Cases with PGT-A embryos
Target sample size
71
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
530-0011
Address
Grand Frront Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
TEL
0663778824
powerhitter000@gmail.com
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
5300011
Address
Grand Frront Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
TEL
0663778824
Homepage URL
powerhitter000@gmail.com
Sponsor or person
Institute
HORAC Grand Front Osaka Clinic
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
HORAC Grand Front Osaka Clinic
Address
Grand Frront Osaka Tower B 15F, 3-1, Ofuka-cho, Kita-ku, Osaka city, Osaka, Japan
Tel
0663778824
powerhitter000@gmail.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
| 2024 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
None
Publication of results
Partially published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
71
Results
ERA testing revealed 49.3% (35/71) receptive and 50.7% (36/71) non-receptive profiles
Overall pregnancy rate after personalized embryo transfer was 35.2% (25/71)
Ongoing pregnancy rate was 25.4% (18/71)
Multivariate analysis showed no significant impact of previous failed cycles on pregnancy rates (adjusted OR = 1.09, 95% CI: 0.89-1.33, p = 0.39)
Results date posted
| 2024 | Year | 12 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age 37.0 years (IQR: 34.5-40.5), median BMI 20.7 kg/m^2 (IQR: 19.4-22.1), median endometrial thickness 9.7mm (IQR: 8.0-11.0)
Participant flow
Of 99 assessed patients, 28 excluded (6 uterine abnormalities, 6 severe male factor, 15 cleavage-stage/PGT-A embryos, 7 second ERA/no ET), 71 analyzed
Adverse events
None reported
Outcome measures
Primary: Pregnancy rate
Secondary: Ongoing pregnancy rate
Plan to share IPD
Yes
IPD sharing Plan description
The data underlying this study will be shared on reasonable request to the corresponding author
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 03 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 03 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 03 | Day |
Other
Other related information
Study design: Single-center retrospective cohort study
Study period: March 2018 to March 2023
Ethical approval: Institutional Review Board of Medical Corporation Sankeikai (approval number: 2017-011)
Analysis method: Multivariate logistic regression analysis assessing relationship between previous failed cycles and pregnancy outcomes, adjusted for age, BMI, and endometrial thickness
Management information
Registered date
| 2024 | Year | 12 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064381
