Sunrise Fertility Center has announced a new clinical trial to evaluate advanced sperm selection devices used in intracytoplasmic sperm injection (ICSI) procedures. This study will compare the PICSI dish and the ZyMot device to determine their efficacy and performance in infertile patients undergoing this specialized fertility treatment.
The trial, not yet recruiting, marks an important step for regulatory and clinical teams in assessing next-generation medical devices for assisted reproduction. Stakeholders in the fertility sector and regulatory affairs will find this trial particularly relevant.
In this article
- What changed?
- What are PICSI and ZyMot?
- Why does this study matter?
- FAQs
- Conclusion
- Disclaimer
- Learn more
What changed?
Sunrise Fertility Center is sponsoring a comparative clinical trial to assess two advanced sperm selection devices in ICSI. This trial is listed on ClinicalTrials.gov but is not yet recruiting. The primary intervention involves the use of the PICSI dish. The study’s outcomes may guide patients and clinics in selecting the most effective device for assisted reproduction.
What are PICSI and ZyMot?
The PICSI dish is a medical device designed to assist embryologists in selecting sperm with the highest fertility potential by using a hyaluronan binding strategy. This method aligns with the principles of physiological sperm selection, adding precision to the ICSI process.
The ZyMot device, meanwhile, employs microfluidic technology to isolate high-quality sperm based on motility and morphology. This device mimics natural biological processes, offering an innovative alternative to conventional selection techniques.
Why does this study matter?
The results of this study will provide key insights into the performance and reliability of PICSI and ZyMot in improving clinical outcomes for infertility treatments. Differences in sperm quality selection methods could significantly impact the success rates of ICSI and patient satisfaction.
For regulatory professionals, the trial highlights how advanced reproductive technologies are evolving to address unmet clinical needs. As these devices are distributed globally, data from this trial may also inform international regulatory submissions and compliance with medical device directives and regulations, such as EU MDR Annex XIV.
FAQs
- What is the primary intervention in this trial?
The use of the PICSI dish to improve sperm selection during ICSI. - Who is sponsoring the trial?
The trial is sponsored by Sunrise Fertility Center. - Is recruitment for the trial active?
No, the trial is not yet recruiting as of the publication date.
Conclusion
This trial signifies a focused effort to innovate and validate advanced sperm selection techniques in ICSI procedures. Collaboration among clinical practitioners, quality assurance teams, and regulatory bodies will be essential to utilize the insights gained from this study.
Disclaimer
This article is intended for informational purposes only and does not constitute legal, clinical, or regulatory advice. Always consult a qualified professional for guidance specific to your situation.
Learn more
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07240779?term=medical+device