Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment270 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations1 site (San Francisco, California)
StatusRecruiting
StartedFebruary 5, 2023
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedSeptember 15, 2026
Trial IDNCT05693220 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.