Recruiting

Robotic Sperm Selection

Sponsor:

Create Fertility Center

Code:

NCT05240469

Conditions

Infertility

Eligibility Criteria

Sex: All

Age: 19 - 43

Healthy Volunteers: Not accepted

Interventions

Automated sperm selection software

Study Details

Brief summary:

Intracytoplasmic sperm injection (ICSI) is one of the standard clinical treatments for infertility. ICSI involves the injection of a single sperm into an oocyte with a sharp micropipette. Injecting a sperm with DNA fragmentation (i.e., physical breakage of the DNA double strands) into the oocyte deterministically lowers the IVF fertilization rate \[1\]\[2\] and increases the miscarriage rate \[3\]\[4\]. Since the invention of ICSI in 1992, single sperm selection in ICSI has been made manually by embryologists, who select sperm by qualitatively choosing sperm with "good" motility and/or morphology based on their empirical experience. This involves significant subjectivity and inconsistency. We have developed a robotic system to select sperm with low sperm DNA fragmentation. Automated sperm selection also eliminates the subjectivity and inconsistency in manual sperm selection. The system consists of a camera to acquire images of sperm and a software to analyze the images. Embryologists select sperm by observing the same sperm characteristics as in the software criteria (e.g., speed etc.), but the software provides a more accurate and quantitative measure of sperm characteristics, thus ensuring the selected sperm have low DNA fragmentation.

Conditions

Infertility

Study ID

NCT05240469

Start date

Jan 20, 2021

Status verified date

Mar, 2024

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 43

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing ICSI
  • Female partner between 19-43 years of age using own or donor oocytes

Exclusion Criteria:

  • Patients who do not provide informed consent
  • Patients with less than 6 mature eggs collected
  • Patients undergoing IVF without ICSI
  • Morphology <4% normal forms
  • 100% immotile sperm
  • Cases where surgically-retrieved sperm is used for ICSI

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Standard sperm selection

In the control group the oocytes will be injected with sperm that is selected by embryologists using conventional methods in the IVF lab.

experimental: Automated sperm selection

The only intervention is the additional sperm selection step using software immediately prior to ICSI.

Interventions

Automated sperm selection software

The software measures both morphology and motility similar to an embryologist but provides a more accurate and consistent measure of sperm characteristics. Embryologists use their experience to qualitatively judge if an individual sperm is "suitable for injection" based on morphology and motility. Similarly, the software follows a two-step process: firstly, a computer vision algorithm measures characteristics of all sperm in a given field, including motility and morphology; secondly, the software algorithm then uses a set of quantitative criteria to categorize and identify the most developmentally competent sperm with normal characteristics. All the characteristics that the software calculate are defined by the WHO guidelines, and the software does not propose or define new parameters.

Primary outcome measure

  • Fertilization rate [ Time Frame: 1 day ]
  • Blastocyst formation rate [ Time Frame: 5 or 6 days ]
  • Embryo morphology grade as evaluated by the SART grading system [ Time Frame: 5 or 6 days ]

Central Contacts and Locations

Central contacts

Clifford L Librach, MD

416-323-7727drlibrach@createivf.com

Locations

CReATe Fertility Centre

Recruiting

Toronto, Ontario, Canada, M5G 1N8

Contacts

Clinical Research Coordinator

416-323-7727researchcoordinator@createivf.com

Justin Tan

416-323-7727justint@createivf.com

Principal Investigator:

Clifford Librach, MD

More Information

Sponsor

Create Fertility Center

Last update posted

Mar 4, 2024

Last verified

Mar, 2024

Keywords

  • In Vitro Fertilization
  • Embryology
  • Oocyte
  • Sperm
  • Automated Sperm Selection
  • DNA Fragmentation Index

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Create Fertility Center on 2024-03-04.