Comparing two methods of sperm preparation for intrauterine insemination
The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05693220 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals assigned female at birth, under the age of 41, who are undergoing intrauterine insemination.
Not a fit: Patients with significant diseases, psychiatric disorders, prior insemination experiences, or those using frozen donor sperm may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pregnancy rates for patients undergoing intrauterine insemination.
How similar studies have performed: Other studies have explored sperm preparation methods, but this specific comparison of microfluidic sorting versus density gradient centrifugation is relatively novel.
Eligibility criteria
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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.