Sperm Preparation Prior to Intrauterine Insemination Study
PIoUS
The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)
1 other identifier
interventional
270
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2023
CompletedStudy Start
First participant enrolled
February 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 3, 2023
March 1, 2023
2.9 years
December 9, 2022
March 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative clinical pregnancy rate
The clinical pregnancy rate by treatment group over the course of IUI treatment
3 treatment cycles, an average of 5 months
Study Arms (2)
Density gradient centrifugation
ACTIVE COMPARATORPatients will undergo sperm preparation by density gradient centrifugation
Zymot sperm separation device
ACTIVE COMPARATORPatients will undergo sperm preparation by the Zymot sperm separation device
Interventions
Sperm preparation with Zymot Multi sperm preparation device
Sperm preparation with density gradient centrifugation
Eligibility Criteria
You may qualify if:
- Patients undergoing intrauterine insemination
- Patient assigned female at birth with age \<41
You may not qualify if:
- Any significant disease or psychiatric disorder that would interfere with the consenting process
- Prior intrauterine insemination
- Use of frozen donor sperm
- Non-English speaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Center for Reproductive Health
San Francisco, California, 94158, United States
Related Publications (2)
Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.
PMID: 31543253BACKGROUNDQuinn MM, Jalalian L, Ribeiro S, Ona K, Demirci U, Cedars MI, Rosen MP. Microfluidic sorting selects sperm for clinical use with reduced DNA damage compared to density gradient centrifugation with swim-up in split semen samples. Hum Reprod. 2018 Aug 1;33(8):1388-1393. doi: 10.1093/humrep/dey239.
PMID: 30007319BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Rosen, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2022
First Posted
January 20, 2023
Study Start
February 5, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
April 3, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share