Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT04818593
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: