Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062690) titled 'Study on the Effectiveness of Physiological Sperm Selection Using Hyaluronic Acid' on Sept. 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 effectiveness of physiological intracytoplasmic sperm injection (PICSI), which selects mature sperm based on their ability to bind to hyaluronic acid, in patients with infertility requiring ICSI by assessing embryo development and pregnancy and delivery outcomes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - On the day of oocyte retrieval, semen is prepared using the standard laboratory procedure. Sperm with hyaluronic acid-binding ability are then selected using a PICSI Dish and used for intracytoplasmic sperm injection (ICSI).

Eligibility: Age-lower limit - 18 years-old

Gender - Female Key inclusion criteria - 1. Patients undergoing infertility treatment at the Reproductive Endocrinology and Infertility Clinic of Tohoku University Hospital and receiving assisted reproductive technology (ART). 2. Patients indicated for intracytoplasmic sperm injection (ICSI). 3. Patients who have received sufficient explanation regarding the study and have voluntarily provided written informed consent to participate in the study and to bear the costs associated with PICSI. 4.Patients meeting at least one of the following criteria: Failure to obtain good-quality embryos following conventional ICSI. Difficulty in sperm selection based solely on morphology and motility due to asthenozoospermia, teratozoospermia, or other sperm abnormalities. Couples with an older male partner. 5.Patients otherwise considered appropriate for PICSI by the principal investigator or study investigators. Key exclusion criteria - 1. Cases in which no motile sperm are identified. 2. Cases undergoing other sperm-selection techniques, such as ZyMOT or intracytoplasmic morphologically selected sperm injection (IMSI). 3. Cases using sperm surgically retrieved by techniques such as testicular sperm extraction (TESE) or microsurgical epididymal sperm aspiration (MESA). 4. Cases in which the female partner is 43 years of age or older at the time of treatment planning. 5. Cases in which no sperm motility is observed and motile sperm cannot be obtained without the use of agents such as pentoxifylline. 6. Patients considered unable to participate appropriately in the study because of psychiatric disease, psychiatric symptoms, or other relevant conditions. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 01 Day Anticipated trial start date - 2026 Year 10 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=R000071775

Disclaimer: Curated by HT Syndication.