NCT05693220

Sperm Preparation Prior to Intrauterine Insemination Study

The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.

Detailed description

Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.

Conditions

• Infertility
• Infertility Secondary
• Infertility Unexplained
• Anovulation
• Fertility Disorders
• Reproductive Issues

Interventions

Type	Name	Description
DEVICE	Zymot Multi sperm separation device	Sperm preparation with Zymot Multi sperm preparation device
OTHER	Density gradient centrifugation	Sperm preparation with density gradient centrifugation

Timeline

• Start date: 2023-02-05
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-01-20
• Last updated: 2023-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study