Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055616) titled 'Validating the embryo culture medium supplemented with antioxidants in IVF cycles of advanced age patients' on Oct. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Vitrolife K.K.

Condition: Condition - Patients seeking ART treatments with in vitro fertilization, embryo culture and transfer. Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 40 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 Size - 340

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063550

Disclaimer: Curated by HT Syndication.