Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062866) titled 'A study comparing ASFI, a fertilization method designed to avoid needle penetration of the oocyte membrane, with standard PIEZO-ICSI' on Sept. 10.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Sugiyama Clinic

Condition: Condition - Infertility in patients scheduled to undergo intracytoplasmic sperm injection (ICSI) as part of assisted reproductive technology Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - The objective of this study is to prospectively compare assisted sperm fusion insemination (ASFI) with PIEZO-ICSI in patients scheduled for ICSI, and to comprehensively evaluate fertilization outcomes, embryo development, PGT-A outcomes in patients undergoing PGT-A, and clinical outcomes after embryo transfer. The study will also evaluate the clinical feasibility of ASFI and factors associated with inability to perform ASFI. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The first month after ethics approval will be designated as an ASFI period, followed by a PIEZO-ICSI period, with the two periods alternating every month thereafter. During ASFI periods, ASFI will be performed when mature oocytes, an immature or degenerated oocyte usable for obtaining zona-bound sperm, sufficient motile sperm, and zona-bound motile sperm are available. Motile sperm bound to the zona pellucida after co-incubation with an immature or degenerated oocyte will be recovered, introduced into the perivitelline space of a mature oocyte, and pressed against the oolemma to facilitate sperm-oocyte adhesion and membrane fusion. If ASFI cannot be performed, PIEZO-ICSI will be performed on the same day and the reason for non-performance will be recorded. Interventions/Control_2 - During PIEZO-ICSI periods, patients will undergo the standard PIEZO-ICSI procedure routinely used at the participating institutions. Subsequent embryo culture, cryopreservation, PGT-A when clinically indicated, and embryo transfer will be performed according to routine clinical practice.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Adult patients scheduled for oocyte retrieval and intracytoplasmic sperm injection (ICSI) at a participating institution. 2. Retrieval cycles using ejaculated sperm. 3. Patients who understand the study and provide consent using a method approved by the ethics committee. 4. Patients considered eligible for study participation by the investigators. Key exclusion criteria - 1. Cycles using surgically retrieved sperm, including testicular sperm. 2. Cases in which an adequate number of motile sperm required for ASFI clearly cannot be obtained. 3. Patients unable to understand the study or provide voluntary informed consent. 4. Patients considered unsuitable for study participation by the investigators. In ASFI periods, absence of an immature/degenerated oocyte or failure to obtain zona-bound sperm after enrollment will be recorded as a reason for inability to perform ASFI rather than as a pre-enrollment exclusion, subject to consistency with the approved protocol. Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 02 Day Date of IRB - 2026 Year 09 Month 02 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071945

Disclaimer: Curated by HT Syndication.