UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055611 |
|---|---|
| Receipt number | R000055455 |
| Scientific Title | Clinical Evaluation of Time-lapse Incubator System in Blastocyst Development: Multi-centre prospective study |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/09/25 12:55:59 |
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Basic information
Public title
Clinical study of Time-Lapse incubator
Acronym
RCT-TLI
Scientific Title
Clinical Evaluation of Time-lapse Incubator System in Blastocyst Development: Multi-centre prospective study
Scientific Title:Acronym
RCT-TLI
Region
| Japan |
Condition
Condition
Patients seeking ART treatments with in vitro fertilization, embryo culture and transfer.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is a multi-centre prospective clinical study to conduct a comparative evaluation of "EmbryoScope+" series time-lapse incubator versus conventional incubator setups in human IVF embryo culture laboratory, using randomly split sibling embryos collected from patients in the per-protocol manner. The resulting data is possibly used in the materials for medical device registration of "EmbryoScope+" series incubator to the authority.
Basic objectives2
Others
Basic objectives -Others
This study aims to evaluate the performance of embryo culture in Time-lapse incubator. It is not designed for treatments or diagnostics of patients themselves, but for continuous culturing and sequential image acquisition of embryos resulted from the insemination of zygotes collected from the patients couples.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Those rates shall be denominated by per M-II oocytes and per-2PN embryo.
(1) Overall blastocyst rate, observed between day 5 and day 7
(2) Good blastocyst rate: Grade 3BB or better between day 5 and day 7
(3) Number of Usable Blastocysts per cycles: embryos meeting the criteria of fresh transfer and freezing of the study clinics
Key secondary outcomes
(1) 2PN rate after the insemination, embryo morphology grades on day 3
(2) Grade AA/AB/BA blastocysts (top-rated blastocysts)
(3) ET outcomes, including HCG+/-, CPR verified by GS in week 7, OPR verified by fetal heartbeats in week 13
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Fertilized oocytes in the treatment cycles which meet the selection criteria after insemination will be randomly split into the test arm and the control arm.
Embryos in the test arm are cultured in the test equipment "EmbryoScope+ time lapse incubator".
Embryos are cultured continuously up to blastocysts stage, usually for 5-7 days from the insemination.
Interventions/Control_2
Embryos in the control arm are cultured in the conventional incubator normally used in the test sites.
Embryos are cultured continuously up to blastocysts stage, usually for 5-7 days from the insemination.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients and treatment cycles must meet all of the following conditions:
(1) Received informed consent (IC) by physician and signed the IC agreement form. The patient age must be between 20 and 50 on the day of signing the agreement.
(2) Shown to be eligible to the standard IVF treatment procedure in the study clinics by the initial diagnosis results collected before starting IVF treatment.
(3) Treatment cycles with six or more of oocytes fertilized normally by either cIVF or ICSI.
Key exclusion criteria
Patients or treatment cycles applicable to any one of the following conditions:
(1) Fertilization is performed with sperms collected through special procedure for male infertility patients: e.g., TESA and TESE.
(2) Fertilization is performed with both cIVF and ICSI in a single treatment cycle.
(3) Any treatment cycles in which an embryo, either in the study arm or in the control arm, is taken out from the culture for embryo transfer before reaching to blastocysts, such as day 2/3 embryo transfer.
(4) Oocytes which require in vitro maturation (IVM) shall be excluded from the sample pool. However, it shall include those treatment cycles found with six or more of normally fertilized oocytes after excluding IVM oocytes.
(5) Patients already been registered in any other clinical studies.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Tanaka |
Organization
St. Mother Hospital
Division name
Infertility treatment
Zip code
807-0825
Address
4-9-12 Orio Yahatanishi Kitakyushu, Fukuoka, JAPAN
TEL
093-601-2000
soumu@stmother.com
Public contact
Name of contact person
| 1st name | Souichi |
| Middle name | |
| Last name | Ogata |
Organization
Vitrolfie K.K.
Division name
Scientific support
Zip code
105-0011
Address
1-3-1 Shibakoen, Ryuen Building 2F, Minato-ku, Tokyo, Japan
TEL
03-6459-4437
Homepage URL
sogata@vitrolife.com
Sponsor or person
Institute
Vitrolife K.K.
Institute
Department
Personal name
Funding Source
Organization
(N/A)
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
St. Mother Hospital
Address
4-9-12 Orio Yahatanishi Kitakyushu, Fukuoka, JAPAN
Tel
093-601-2000
soumu@stmother.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
(1) セントマザー産婦人科医院
(2) 医療法人 オーク会 オーク銀座レディースクリニック
(3) 神戸ARTクリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 01 | 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
410
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055455
