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Sperm Preparation

Sperm Preparation Techniques for Infertility (PIoUS Trial)

N/A
Recruiting
Led By Mitchell Rosen, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient assigned female at birth with age <41
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 treatment cycles, an average of 5 months
Awards & highlights

PIoUS Trial Summary

This trial compares two methods of sorting sperm to help couples become pregnant via intrauterine insemination.

Who is the study for?
This trial is for individuals assigned female at birth, under the age of 41, who are undergoing intrauterine insemination due to anovulation or unexplained infertility. It's not suitable for those with significant diseases or psychiatric disorders that affect consent, users of frozen donor sperm, non-English speakers, or those with prior intrauterine inseminations.Check my eligibility
What is being tested?
The study compares two methods of preparing sperm before intrauterine insemination: Zymot Multi (a microfluidic sorting device) and density gradient centrifugation. The goal is to see which method leads to better pregnancy outcomes in a randomized controlled setting.See study design
What are the potential side effects?
Since this trial focuses on sperm preparation methods rather than medications, there are no direct side effects like you'd expect from drugs. However, general risks associated with intrauterine insemination may still apply.

PIoUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman under 41 years old.

PIoUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 treatment cycles, an average of 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 treatment cycles, an average of 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative clinical pregnancy rate

PIoUS Trial Design

2Treatment groups
Active Control
Group I: Density gradient centrifugationActive Control1 Intervention
Patients will undergo sperm preparation by density gradient centrifugation
Group II: Zymot sperm separation deviceActive Control1 Intervention
Patients will undergo sperm preparation by the Zymot sperm separation device

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,285 Total Patients Enrolled
Mitchell Rosen, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
376 Total Patients Enrolled

Media Library

Density gradient centrifugation (Sperm Preparation) Clinical Trial Eligibility Overview. Trial Name: NCT05693220 — N/A
Anovulation Research Study Groups: Density gradient centrifugation, Zymot sperm separation device
Anovulation Clinical Trial 2023: Density gradient centrifugation Highlights & Side Effects. Trial Name: NCT05693220 — N/A
Density gradient centrifugation (Sperm Preparation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05693220 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollees being accepted into this research project currently?

"Affirmative. The details on clinicaltrials.gov verify that the said medical trial is currently recruiting applicants. This study was initially published on February 1st 2023 and most recently updated on January 12th 2023, with a total of 270 participants sought from one location."

Answered by AI

What is the current capacity of enrollees for this clinical experiment?

"Affirmative. The information located on clinicaltrials.gov confirms that this investigation is actively in search of volunteers, having first been posted on February 1st 2023 and most recently updated December 1st 2023. It requires 270 participants at one site to fulfil its requirements."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Nevada
What site did they apply to?
UCSF Center for Reproductive Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Sperm Preparation Prior to Intrauterine Insemination Study
2023. "Sperm Preparation Prior to Intrauterine Insemination Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05693220.
All > Infertility
~159 spots leftby Dec 2025
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