A Prospective, Parallel-group, Non-inferiority Study to Compare the Efficacy of an Automated Sperm Selection Method Versus Manual Sperm Selection for ICSI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Create Fertility Center
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Blastocyst formation rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Evaluation of patient demographic and stimulation cycle characteristics for confounding variables.(5 or 6 days)
- Differences in early embryo cleavage divisions and late developmental (blastocyst) morphokinetics.(5 or 6 days)
- Differences in the proportion of euploid and aneuploid embryos between the two groups(5 or 6 days)