Clinical trial NCT05240469: Automated Sperm Selection
Official title: A Prospective, Parallel-group, Non-inferiority Study to Compare the Efficacy of an Automated Sperm Selection Method Versus Manual Sperm Selection for ICSI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Keywords: In Vitro Fertilization
Embryology
Oocyte
Sperm
Automated Sperm Selection
DNA Fragmentation Index
Lead sponsor: Create Fertility Center
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2022-02-15
Enrollment: 330
Sex: ALL
Minimum age (years): 19
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fertilization rate
timeFrame: 1 day
measure: Blastocyst formation rate
timeFrame: 5 or 6 days
measure: Embryo morphology grade as evaluated by the SART grading system
timeFrame: 5 or 6 days
Secondary outcomes:
measure: Differences in early embryo cleavage divisions and late developmental (blastocyst) morphokinetics.
timeFrame: 5 or 6 days
measure: Differences in the proportion of euploid and aneuploid embryos between the two groups
timeFrame: 5 or 6 days
measure: Evaluation of patient demographic and stimulation cycle characteristics for confounding variables.
timeFrame: 5 or 6 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: CReATe Fertility Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Yu Sun, PhD
role: PRINCIPAL_INVESTIGATOR
References: