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.

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.

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

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared at the discretion of the PI.

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

The investigator who proposed to use the data will have access to the data at the discretion of the PI. Requests should be directed to Rani.Fritz@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Baseline data were collected only on the level of the participants (not oocyte units). The overall number of baseline participants represents individuals (n = 66) from dyads that completed the trial. Information from one dyad (2 individuals) were not collected.

Up to 2 weeks post-embryo transfer

PI monitored for adverse events/serious adverse events/all-cause mortality. The number of participants at Risk (n = 33) represents the number of dyads assigned to each intervention for whom adverse event/serious adverse event/all-cause mortality data were collected.