Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05693220
Status:
RECRUITING
Last Update Posted:
2023-04-03
First Post:
2022-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sperm Preparation Prior to Intrauterine Insemination Study
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIoUS
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: