Comparing two methods of sperm preparation for intrauterine insemination
Official title: The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)
Run by University of California, San Francisco · NCT05693220 · Data updated 2026-11-12
This study is testing which of two sperm preparation methods helps couples trying to get pregnant through intrauterine insemination achieve better pregnancy outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | February 5, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT05693220 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals assigned female at birth, under the age of 41, who are undergoing intrauterine insemination.
✕Probably not a fit
Patients with significant diseases, psychiatric disorders, prior insemination experiences, or those using frozen donor sperm may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a randomized controlled trial that compares two sperm preparation methods: density gradient centrifugation and microfluidic sperm sorting using the Zymot Multi device. Participants will be assigned to one of the two methods while undergoing intrauterine insemination over a three-month treatment period. The study aims to evaluate the cumulative pregnancy outcomes of each method, with follow-up until 8-10 weeks of pregnancy to assess results. Standard treatment plans will be followed as designed by the participants' fertility physicians.
Why it matters
Potential benefit: If successful, this study could improve pregnancy rates for patients undergoing intrauterine insemination.
How similar studies have gone: Other studies have explored sperm preparation methods, but this specific comparison of microfluidic sorting versus density gradient centrifugation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing intrauterine insemination * Patient assigned female at birth with age \<41 Exclusion Criteria: * Any significant disease or psychiatric disorder that would interfere with the consenting process * Prior intrauterine insemination * Use of frozen donor sperm * Non-English speaker
Where it's running
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UCSF Center for Reproductive Health
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Mitchell Rosen, MD — University of California, San Francisco
- Study coordinator: Alisha T Tolani, MD
- Email: alisha.tolani@ucsf.edu
- Phone: 6282867307
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.