InfertilityPIoUSNCT05693220
Sperm Preparation Prior to Intrauterine Insemination Study
A study testing Zymot Multi sperm separation device and Density gradient centrifugation in people with Infertility and Infertility Secondary, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility, Infertility Secondary, Infertility Unexplained
- What is being tested?
- Zymot Multi sperm separation device and Density gradient centrifugation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing intrauterine insemination
- Patient assigned female at birth with age <41
Who cannot join
- Any significant disease or psychiatric disorder that would interfere with the consenting process
- Prior intrauterine insemination
- Use of frozen donor sperm
- Non-English speaker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elena Hoskin contact
United States1 site, 1 recruiting
- Recruiting
UCSF Center for Reproductive Health
San Francisco, California, 94158
Alisha T Tolani, MD, 628-286-7307, alisha.tolani@ucsf.edu
Elena Hoskin, elena.hoskin@ucsf.edu
About this study
Official title: The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)
This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.
Read the detailed description
Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.
- Conditions
- Infertility, Infertility Secondary, Infertility Unexplained, Anovulation, Fertility Disorders, Reproductive Issues
- Being tested
- Zymot Multi sperm separation device, Density gradient centrifugation
- Keywords
- Intrauterine Insemination, Insemination, Fertility, Infertility
- Medical subject headings
- Infertility, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zymot Multi sperm separation deviceDevice
Sperm preparation with Zymot Multi sperm preparation device
Density gradient centrifugationOther
Sperm preparation with density gradient centrifugation
| Study group | Role | What they receive |
|---|---|---|
| Density gradient centrifugation | Active comparator | Patients will undergo sperm preparation by density gradient centrifugation Receives: Other: Density gradient centrifugation |
| Zymot sperm separation device | Active comparator | Patients will undergo sperm preparation by the Zymot sperm separation device Receives: Device: Zymot Multi sperm separation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative clinical pregnancy rate
The clinical pregnancy rate by treatment group over the course of IUI treatment
Measured: 3 treatment cycles, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start5 Feb 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Rosen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693220
- Sponsor's protocol ID
- 22-36913
- Acronym
- PIoUS
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31543253Quinn 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.
PubMed 30007319
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)
- ClinicalTrials.gov ID
- NCT05693220
- Acronym / sponsor ID
- PIoUS / 22-36913
- Conditions
- Infertility, Infertility Secondary, Infertility Unexplained, Anovulation, Fertility Disorders, Reproductive Issues
- Keywords
- Intrauterine Insemination, Insemination, Fertility, Infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.
Detailed description
Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Density gradient centrifugation | Active comparator | Other: Density gradient centrifugationPatients will undergo sperm preparation by density gradient centrifugation |
| Zymot sperm separation device | Active comparator | Device: Zymot Multi sperm separation devicePatients will undergo sperm preparation by the Zymot sperm separation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing intrauterine insemination
- Patient assigned female at birth with age <41
Key exclusion criteria (4 listed)
- Any significant disease or psychiatric disorder that would interfere with the consenting process
- Prior intrauterine insemination
- Use of frozen donor sperm
- Non-English speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zymot Multi sperm separation deviceSperm preparation with Zymot Multi sperm preparation device | Device | Zymot sperm separation device |
| Density gradient centrifugationSperm preparation with density gradient centrifugation | Other | Density gradient centrifugation |
Primary outcome
Cumulative clinical pregnancy rate
Time frame: 3 treatment cycles, an average of 5 months
The clinical pregnancy rate by treatment group over the course of IUI treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 31543253Gode 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.
- Background: PubMed 30007319Quinn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Hoskin contact
Mitchell Rosen, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zymot Multi sperm separation device and Density gradient centrifugation in people with Infertility and Infertility Secondary, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisha T Tolani, MD (6282867307, alisha.tolani@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative clinical pregnancy rate (time frame: 3 treatment cycles, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693220, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.