A non-inferiority study to assess the safety and performance of the Felix System vs the dual Discontinuous Gradient Centrifugation and Swim-Up method to isolate spermatozoa prior to its use in human intracytoplasmic spermatozoa injection (ICSI) assisted reproductive technology (ART) - A non-inferiority study to assess the safety and performance of the Felix System vs the dual Discontinuous Gradient Centrifugation and Swim-Up method to isolate spermatozoa prior to its use in human intracytoplasmic spermatozoa injection (ICSI) assisted reproductive technology (ART)

Reproduction Clinic Osaka0 个研究点目标入组 52 人开始时间: 2023年1月11日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Spermatozoa concentration < 2,000,000 / mL assessed using a Makler on the treatment day 2.Total motility < 10% assessed using a Makler on the treatment day 3.Participants having cleavage embryo culture and transfer 4.Participants intending on having more than one embryo implanted during this cycle (i.e., couple does not wish to have a singleton pregnancy), if an embryo transfer is elected 5.Participants undergoing standard IVF insemination 6.Any surgically retrieved spermatozoa samples 7.Severe universal morphological defects of the head or tail such a headless, pinheads or globozoospermic spermatozoa or gross tail defects 8.Donor spermatozoa 9.Donor oocytes 10.Frozen spermatozoa 11.Frozen oocytes 12.Participants with less than 4 mature oocytes during the current round of OPU 13.Participants with a history of poor oocyte yield in the past 14.Known HIV-positive or other virally positive samples

发起方