UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058969 |
|---|---|
| Receipt number | R000067437 |
| Scientific Title | Ex Vivo Gamma Globulin Therapy for Infertile Women with Anticentromere Autoantibodies: A Single-Arm, Historically Controlled Cohort Study |
| Date of disclosure of the study information | 2025/09/10 |
| Last modified on | 2025/09/02 17:21:29 |
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Basic information
Public title
Ex Vivo Gamma Globulin Therapy for Infertile Women with Anticentromere Autoantibodies
Acronym
EVITA study
Scientific Title
Ex Vivo Gamma Globulin Therapy for Infertile Women with Anticentromere Autoantibodies: A Single-Arm, Historically Controlled Cohort Study
Scientific Title:Acronym
EVITA study
Ex VIvo gamma globulin therapy for infertile women with anTicentromere Autoantibodies
Region
| Japan |
Condition
Condition
Anticentromere autoantibody-related female infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anticentromere autoantibodies may contribute to repeated IVF-ET failures. We previously demonstrated that anticentromere antibody levels are associated with infertility in a titer-dependent manner, with no pregnancies observed at titers of 1:1,280 or higher (Reprod Biomed Online, 2024). More recently, in animal experiments, we found that anticentromere antibodies directly impair oocyte meiosis. Specifically, when anticentromere antibodies were introduced into oocytes, they disrupted chromosome alignment during metaphase II, leading to chromosome segregation errors (Am J Reprod Immunol, 2024).
Although systemic glucocorticoid therapy has been reported for this condition, its efficacy remains unproven. Drawing inspiration from high-dose intravenous immunoglobulin therapy for autoimmune diseases, we hypothesize that ex vivo treatment of oocytes with immunoglobulin neutralizes the effects of anticentromere antibodies. Because immunoglobulin is a physiological component of follicular fluid, culturing oocytes in immunoglobulin is unlikely to be harmful to oocytes or embryos.
In this study, we aim to evaluate whether culturing oocytes in immunoglobulin-supplemented media enhances embryonic development and pregnancy rate in anticentromere antibody-positive infertile women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Good-quality blastocyst formation rate
Live birth rate
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Ex vivo gamma globulin supplementation to culture media
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
| 30 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Female
Key inclusion criteria
Women diagnosed with infertility who desire to conceive.
Positive for anticentromere antibody (titer 1:640 or higher).
Key exclusion criteria
History of clinical pregnancy.
History, signs, or symptoms suggestive of autoimmune diseases.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Makio |
| Middle name | |
| Last name | Shozu |
Organization
Medical Mycology Research Center, Chiba University
Division name
Evolution and Reproduction
Zip code
260-8673
Address
1-8-1 Inohana, Chuoku, Chiba
TEL
043-226-2492
shozumakio@chiba-u.jp
Public contact
Name of contact person
| 1st name | Makio |
| Middle name | |
| Last name | Shozu |
Organization
Natural ART Clinic at Nihonbashi
Division name
Clinical Laboratory
Zip code
103-6008
Address
Nihonbashi Tower 8F, 2-7-1, Nihonbashi, Chuoku, Tokyko
TEL
03-6262-5757
Homepage URL
mail@naturalart.or.jp
Sponsor or person
Institute
Natural ART Clinic at Nihonbashi
Institute
Department
Personal name
Funding Source
Organization
Natural ART Clinic at Nihonbashi
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
Medical Ethics Committee of Towako
Address
Nihonbashi Tower 8F, 2-7-1, Nihonbashi, Chuoku, Tokyko
Tel
0362625760
mail@naturalart.or.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
| 2025 | Year | 09 | Month | 10 | 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
17
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 | 02 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | 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
| 2025 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067437
