Clinical trial NCT04818593: A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI
Official title: A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ART
Keywords: ICSI
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria for Patients:

1. Patient(s) over 18 years of age
2. Patient(s) capable of providing informed consent
3. Use or possible use of ICSI for oocyte insemination
4. At least 6 mature oocytes at time of insemination via ICSI

Exclusion Criteria for Patients:

1. Patient under 18 y/o
2. Patients not capable of providing informed consent
3. Use of IVF for insemination
4. Less than 6 mature oocytes at time of rertrieval
5. Anonymous donor sperm source
6. Surgically retrieved sperm
7. Sperm sample not sufficient for use with ZyMot device

Inclusion Criteria for Donors:

1. Donor(s) over 18 years of age
2. Donor(s) capable of providing informed consent
3. Use of ejaculate sperm, fresh or frozen, for insemination
4. Sufficient sperm for use of ZyMot

Exclusion Criteria for Donors:

1. Anonymous donors

Primary outcomes:
measure: Percentage of Good Quality Blastocyst Formation
timeFrame: Culture Day 5 or 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Reproductive Specialists of NY
state: New York
Study officials:
affiliation: NYU Langone Health
name: Rani Fritz, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References: