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

NCT ID: NCT04818593

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-18
• Study Completion Date: 2021-11-29

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.

Conditions

ART

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZyMot Separation

Treatment

Group Type: EXPERIMENTAL

ZyMot Multi Sperm Separation Device (850 ul)

Intervention Type: DEVICE

850 uL of untreated semen will be directly deposited into the inlet port of the ZyMotTM Multi device, followed by placement of 750 uL culture medium in the outlet port and throughout the upper collection chamber. The device will then be incubated in a humidified 37C CO2 incubator for 30 minutes. During incubation, the healthiest and most motile sperm will swim through the microporous filter and into the upper collection chamber, where they will be recovered via the outlet port. 500 uL of the sperm sample will be removed and placed in a separate tube for analysis and insemination.

Density Gradient Centrifugation

Control

Group Type: ACTIVE_COMPARATOR

Density Gradient Centrifugation

Intervention Type: OTHER

Density gradient centrifugation will be performed using a one-layer preparation of 90% Isolate in 15 mL conical tubes. Semen will be layered over 1 mL of gradient and then centrifuged for 15 min at 300xg. The supernatant will be removed and discarded. The sperm pellet will be washed by mixing with Multipurpose Handling Medium Complete and centrifuging the sample for 5 min at 400xg. After the wash, the supernatant is removed and discarded and the pellet is re-suspended in culture medium, assessed for sperm parameters, and held at room temperature until insemination.

Interventions

ZyMot Multi Sperm Separation Device (850 ul)

850 uL of untreated semen will be directly deposited into the inlet port of the ZyMotTM Multi device, followed by placement of 750 uL culture medium in the outlet port and throughout the upper collection chamber. The device will then be incubated in a humidified 37C CO2 incubator for 30 minutes. During incubation, the healthiest and most motile sperm will swim through the microporous filter and into the upper collection chamber, where they will be recovered via the outlet port. 500 uL of the sperm sample will be removed and placed in a separate tube for analysis and insemination.

Intervention Type: DEVICE

Density Gradient Centrifugation

Density gradient centrifugation will be performed using a one-layer preparation of 90% Isolate in 15 mL conical tubes. Semen will be layered over 1 mL of gradient and then centrifuged for 15 min at 300xg. The supernatant will be removed and discarded. The sperm pellet will be washed by mixing with Multipurpose Handling Medium Complete and centrifuging the sample for 5 min at 400xg. After the wash, the supernatant is removed and discarded and the pellet is re-suspended in culture medium, assessed for sperm parameters, and held at room temperature until insemination.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

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

1. Anonymous donors

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rani Fritz, DO, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Reproductive Specialists of NY

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21-00021

Identifier Type: -

Identifier Source: org_study_id