NCT04496232

Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Ganin Fertility Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.

Detailed description

Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.

Conditions

• Male Infertility

Interventions

Type	Name	Description
DEVICE	PICSI	Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate
OTHER	Second ejaculate	Semen processing by density gradient centrifugation for the second ejaculate

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-08-03
• Last updated: 2022-08-09

Locations

1 site across 1 country: Egypt