Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058969) titled 'Ex Vivo Gamma Globulin Therapy for Infertile Women with Anticentromere Autoantibodies' on Sept. 10.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Natural ART Clinic at Nihonbashi

Condition: Condition - Anticentromere autoantibody-related female infertility Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - Ex vivo gamma globulin supplementation to culture media

Eligibility: Age-lower limit - 30 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 Size - 15

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067437

Disclaimer: Curated by HT Syndication.