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

Memphasys Limited0 个研究点目标入组 104 人开始时间: 2022年3月18日最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•Male Inclusion Criteria:
•1. Over 18 years of age
•2. Has been abstinent from ejaculating for the three days prior to providing a semen sample.
•3. Able to provide enough raw semen (measured using a serological pipette) to ensure study assessments can be completed in addition to standard of care based on the following criteria: a) 1.5mL of raw semen is required if the initial concentration is greater than 80M/mL and total motility is greater than 40% b) 1.9mL of raw semen is required if initial concentration is between 21-80M/mL and total motility is greater than 40% c) 1.9mL of raw semen is required if initial concentration is greater than 80M/mL and total motility between 4-40% d) 2.3mL of raw semen is required if the above criteria are not met
•4. Participants scheduled to undergo ICSI
•Female Inclusion Criteria:
•1. Participants having blastocyst culture and either an embryo transfer or freezing embryo(s)
•2. Minimum Anti Mullerian Hormone (AMH) of 6 lU/L during screening
•3. Between 18 and 43 years of age at the time of booking of cycle

•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 In Vitro Fertilisation (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 Ovum Pick up (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

Memphasys Limited