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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 43
Healthy Volunteers: f
View:

• Patients undergoing ICSI

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

Locations
Other Locations
Canada
CReATe Fertility Centre
RECRUITING
Toronto
Contact Information
Primary
Clifford L Librach, MD
drlibrach@createivf.com
416-323-7727
Time Frame
Start Date: 2021-01-20
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 330
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Toronto
Leads: Create Fertility Center

This content was sourced from clinicaltrials.gov