A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI

Not Applicable

Completed

Conditions: ART

Interventions: Device: ZyMot Multi Sperm Separation Device (850 ul)
Other: Density Gradient Centrifugation

Registration Number: NCT04818593

Lead Sponsor: NYU Langone Health

Brief Summary: The primary objective of this study is to evaluate whether the percentage of good quality embryo formation following Intracytoplasmic Sperm Injection (ICSI) is improved with the use of ZyMot method of microfluidic sperm separation compared to density gradient.

Detailed Description: During an in vitro fertilization (IVF) cycle, eggs are removed from a woman's ovaries via a minor surgical procedure and are inseminated with sperm in order to create embryos. The insemination process can be via standard IVF or intracytoplasmic sperm injection (ICSI.) Standard IVF is the process of placing thousands of sperm in a culture dish with one or more eggs and allowing them to interact on their own. ICSI is the process by which one sperm is directly injected into each egg.

Prior to using the sperm for insemination, a semen sample is processed and washed in order to obtain the healthiest sperm. A standard sperm preparation procedure is density gradient, in which the sperm is spun via centrifugation and separated from the seminal fluid. An alternate method is via microfluidics, by which the sperm swim up a microfluidic gradient created by a microporous filter between two chambers of a device. Sperm that are capable of navigating through this filter and reaching the end chamber are presumed to be the healthiest sperm. There is some data revealing that ZyMot microfluidics yields healthier sperm compared to the density gradient technique.

The aim of the study is to evaluate whether good quality embryo formation is any different following insemination with sperm separated by microfluidics compared to density gradient.

On the day of oocyte retrieval, the sperm sample will be split between the two different processing methods: density gradient and ZyMot microfluidics. In the event that there are 6 or more mature oocytes and ICSI will be used for insemination, half of the oocytes will be inseminated with sperm processed by density gradient and half with sperm processed by ZyMot microfluidics. The percentage of good quality embryo formation will be compared between the two groups.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZyMot Separation	ZyMot Multi Sperm Separation Device (850 ul)	Treatment
Density Gradient Centrifugation	Density Gradient Centrifugation	Control

Primary Outcome Measures

Name	Time	Method
Percentage of Good Quality Blastocyst Formation	Culture Day 5 or 6	Good quality embryos will be defined as blastocyst stage embryos on day 5 or 6 of culture with an overall quality grade of good or fair. Embryo morphology assessment includes two parts: an Overall Grade and the Stage. Grading is a subjective assessment of the overall quality of the embryo as good, fair, or poor, and is based on assessment of certain characteristics of the embryo, such as fragmentation, symmetry, inner cell mass (ICM) quality and trophectoderm quality. The percentage will be reported for both arms (ZyMot compared to density gradient).

Secondary Outcome Measures