UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055616 |
|---|---|
| Receipt number | R000063550 |
| Scientific Title | Validating the embryo culture medium supplemented with antioxidants in IVF cycles of advanced age patients |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2024/09/26 08:34:48 |
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Basic information
Public title
Validating the embryo culture medium supplemented with antioxidants in IVF cycles of advanced age patients
Acronym
AOX medium for 40s patients
Scientific Title
Validating the embryo culture medium supplemented with antioxidants in IVF cycles of advanced age patients
Scientific Title:Acronym
AOX medium for 40s patients
Region
| Japan |
Condition
Condition
Patients seeking ART treatments with in vitro fertilization, embryo culture and transfer.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the culture medium supplemented with three antioxidants, alpha-lipoic acid, acetyl-L-cysteine and acetyl-L-carnitine, for handling and culturing gametes and embryos collected from IVF patients aged 40 and 45 years old, and study the potential impact on the success rates of pre-implantation embryo culture as well as embryo transfer outcomes.
Basic objectives2
Others
Basic objectives -Others
This study aims to evaluate the performance of embryo culture medium supplemented with antioxidants. It is not designed for treatments or diagnostics of patients themselves, but for handling of gametes (oocytes and sperm) and continuous culturing of embryos collected from the patients couple seeking infertility treatment with ART.
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) Good blastocyst rate (via Gardner's criteria): Grade 3BB or better between day 5 and day 7
(2) Number of Usable Blastocysts per cycles: embryos meeting the criteria of fresh embryo transfer or vitrification
(3) Overall blastocyst rate, observed between day 5 and day 7
Key secondary outcomes
(1) 2PN rate after the insemination,
(2) Good embryos on day 3, consist of 6 or more blastomeres with Veeck criteria at 3 or better
(3) ET outcomes: embryo implantation defined by HCG+, CPR verified by GS in week 5, OPR verified by fetal heartbeats in week 6 or after
(4) AA, AB, BA blastocysts rates
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Oocytes and sperm samples collected from patients who meet the selection criteria will be handled and cultured in either Gx-series medium (study arm), and in G-Plus series medium (control arm). The embryo culture lab alternates these two series of medium for gametes handling and pre-implantation embryo culture in every months during the study period.
These treatment cycles assigned to "study arm" month use Gx series medium for gamete handling and pre-implantation embryo culture.
Interventions/Control_2
These treatment cycles assigned to "control arm" month use G-Plus series medium for gamete handling and pre-implantation embryo culture.
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
| 40 | years-old | <= |
Age-upper limit
| 46 | years-old | > |
Gender
Female
Key inclusion criteria
Patients and treatment cycles must meet all of the following conditions:
(1) Received informed consent (IC) by physician. The patient age must be between 40 and 45 on the day of IC consultation.
(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.
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) Patients who have already been registered in any other clinical studies.
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Kuroda |
Organization
Sugiyama clinic Marunouchi
Division name
Center for Reproductive Medicine and Endoscopy
Zip code
100-0005
Address
Marunouchi 1-6-2, Chiyoda-ku, Tokyo
TEL
03-5222-1500
kuroda@sugiyama.or.jp
Public contact
Name of contact person
| 1st name | Souichi |
| Middle name | |
| Last name | Ogata |
Organization
Vitrolife K.K.
Division name
Scientific support
Zip code
105-0011
Address
1-3-1 Shibakoen, Ryuen Building 8F, 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
Sugiyama clinic Institutional review board
Address
Nishishinjuku 1-19-6, Yamate-Shinjuku building 5F, Shinjuku-ku, Tokyo
Tel
03-5381-3000
kanda@sugiyama.clinic
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
| 2025 | Year | 10 | 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
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
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063550
