Automated Sperm Selection

March 1, 2024 updated by: Create Fertility Center

A Prospective, Parallel-group, Non-inferiority Study to Compare the Efficacy of an Automated Sperm Selection Method Versus Manual Sperm Selection for ICSI

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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]. Patients with high sperm DNA fragmentation suffer from repeated IVF failures [8], causing heavy burdens on families and the healthcare system. 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. The software automatically measures the 9 motility parameters (e.g., curvilinear speed, path linearity, etc.) and 11 morphology parameters (e.g., head ellipticity, midpiece width etc.). All these 20 parameters are defined by the WHO guidelines [9]. 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.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1N8
        • Recruiting
        • Create Fertility Centre
        • Principal Investigator:
          • Clifford Librach, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: 1 day
Fertilization is defined as the visualization of 2 pronuclear at day 1 post ICSI. The proportion of fertilized eggs for each patient will be calculated as fertilization rate. Each patient's data will be aggregated to calculate the overall fertilization rate for all patients.
1 day
Blastocyst formation rate
Time Frame: 5 or 6 days
The proportion of fertilized embryos classified as blastocysts at day 5 or day 6 of development.
5 or 6 days
Embryo morphology grade as evaluated by the SART grading system
Time Frame: 5 or 6 days
The morphology grade (good, fair, poor) for each embryo will be evaluated. Grades for all embryos of each patient will be summarized.
5 or 6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in early embryo cleavage divisions and late developmental (blastocyst) morphokinetics.
Time Frame: 5 or 6 days

Embryo morphokinetic parameters will be calculated from time-lapse embryo development videos using an EmbryoScope embryo culture system. The evaluated morphokinetic parameters for each embryo include:

  • time of pronuclei formation
  • time of cleavage to a two-cell embryo
  • time of cleavage to a three-cell embryo
  • time of cleavage to a four-cell embryo
  • time of cleavage to a six-cell embryo
  • time of cleavage to a eight-cell embryo
  • time to full blastocyst
5 or 6 days
Differences in the proportion of euploid and aneuploid embryos between the two groups
Time Frame: 5 or 6 days
Embryo ploidy will be evaluated by preimplantation genetic testing technique for aneuploidy.
5 or 6 days
Evaluation of patient demographic and stimulation cycle characteristics for confounding variables.
Time Frame: 5 or 6 days
We will also compare primary outcome measures (fertilization rate, PGT-A results, blastocyst formation rate, embryo grade) of all embryos in the study (control and study group) to the overall rates in the clinic as a measure of quality assurance of the study.
5 or 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Create Fertility Center

Collaborators

University of Toronto

Investigators

  • Principal Investigator: Yu Sun, PhD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2395

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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