Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062497) titled 'Evaluation of the Clinical Utility of Physiological Sperm Selection Using Hyaluronic Acid' on Oct. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Infertility requiring intracytoplasmic sperm injection (ICSI) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the clinical utility of physiological intracytoplasmic sperm injection (PICSI) using hyaluronic acid for sperm selection in patients with infertility requiring intracytoplasmic sperm injection (ICSI). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - On the day of oocyte retrieval, physiological sperm selection using hyaluronic acid will be performed for spermatozoa to be used for intracytoplasmic sperm injection (ICSI). Motile spermatozoa capable of binding to hyaluronic acid will be selected as mature spermatozoa and used for ICSI (PICSI). The intervention will be performed once per oocyte retrieval cycle, with an intervention period of one day. Embryos will subsequently be cultured according to standard assisted reproductive technology procedures, and embryo transfer will be performed using the resulting embryos. Embryo development, pregnancy, and pregnancy outcomes will be followed.

Eligibility: Age-lower limit - 18 years-old

Gender - Female Key inclusion criteria - Patients who meet all of the following criteria will be eligible:

1.Patients undergoing infertility treatment and assisted reproductive technology at our institution. 2.Patients for whom intracytoplasmic sperm injection (ICSI) is indicated. 3.Patients with a history of failure to obtain good-quality embryos following conventional ICSI; patients in whom sperm selection based on morphology and motility is difficult due to asthenozoospermia, teratozoospermia, or other sperm abnormalities; or patients with advanced paternal age. 4.Patients who have received sufficient information about the study and have provided written informed consent to participate voluntarily. 5.Patients otherwise considered appropriate for participation by the principal investigator or a study investigator. Key exclusion criteria - Patients who meet any of the following criteria will be excluded:

1.Patients who do not meet the inclusion criteria. 2.Patients who do not provide written informed consent to participate in the study. 3.Patients with no motile spermatozoa for whom pharmacological stimulation, such as pentoxifylline treatment, is required to obtain motile spermatozoa. 4.Patients considered unable to participate in the study due to psychiatric disorders, psychiatric symptoms, or other relevant conditions. 5.Patients otherwise consider Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 01 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2031 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071539

Disclaimer: Curated by HT Syndication.