Automated selection of sperm for infertility treatment
A Prospective, Parallel-group, Non-inferiority Study to Compare the Efficacy of an Automated Sperm Selection Method Versus Manual Sperm Selection for ICSI
This study is testing a new robotic system that helps choose the best sperm for infertility treatment to see if it can improve success rates for people undergoing IVF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 19 Years to 43 Years |
| Sex | All |
| Sponsor | Create Fertility Center Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05240469 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on improving the process of intracytoplasmic sperm injection (ICSI) by utilizing a robotic system for sperm selection. The system employs a camera and software to analyze sperm images, measuring various motility and morphology parameters to identify sperm with low DNA fragmentation. This automated approach aims to reduce the subjectivity and inconsistency associated with manual sperm selection by embryologists, potentially leading to better IVF outcomes for patients with infertility issues. The trial will include patients undergoing ICSI with specific eligibility criteria to ensure the effectiveness of the automated selection process.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing ICSI with a female partner aged between 19-43 years using their own or donor oocytes.
Not a fit: Patients who may not benefit include those with less than 6 mature eggs collected or those undergoing IVF without ICSI.
Why it matters
Potential benefit: If successful, this approach could significantly improve fertilization rates and reduce miscarriage rates for patients undergoing IVF.
How similar studies have performed: While the concept of automated sperm selection is innovative, similar studies have shown promise in improving sperm selection methods, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- CReATe Fertility Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Yu Sun, PhD — University of Toronto
- Study coordinator: Clifford L Librach, MD
- Email: drlibrach@createivf.com
- Phone: 416-323-7727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.