ClinicalTrials.gg
RecruitingNCT05693220PIoUSUpdated Sep 15, 2026

Sperm Preparation Prior to Intrauterine Insemination Study

An interventional study of Zymot Multi sperm separation device and Density gradient centrifugation in Infertility, Infertility Secondary and Infertility Unexplained, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Infertility
  • Infertility Secondary
  • Infertility Unexplained
  • Anovulation
  • Fertility Disorders
  • Reproductive Issues

Keywords

  • Intrauterine Insemination
  • Insemination
  • Fertility
  • Infertility
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 270 is above the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing intrauterine insemination
  • Patient assigned female at birth with age \<41

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
270 participants (estimated)

Study arms

  • Active comparator
    Density gradient centrifugation

    Patients will undergo sperm preparation by density gradient centrifugation

    Other: Density gradient centrifugation

  • Active comparator
    Zymot sperm separation device

    Patients will undergo sperm preparation by the Zymot sperm separation device

    Device: Zymot Multi sperm separation device

Interventions

  • DeviceZymot Multi sperm separation device

    Sperm preparation with Zymot Multi sperm preparation device

  • OtherDensity gradient centrifugation

    Sperm preparation with density gradient centrifugation

06

What researchers measure

Primary outcomes

  1. Cumulative clinical pregnancy rate

    The clinical pregnancy rate by treatment group over the course of IUI treatment

    Time frame: 3 treatment cycles, an average of 5 months

07

Study locations

1 of 1 sites recruiting
  • UCSF Center for Reproductive Health
    San Francisco, California 94158, United States
    Recruiting
08

References and documents

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 31543253 ↗
  • Quinn 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05693220
Responsible party
Sponsor
First posted
Jan 20, 2023
Start date
Feb 5, 2023
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Alisha T Tolani, MD
Contact
alisha.tolani@ucsf.edu
6282867307
Elena Hoskin
Contact
elena.hoskin@ucsf.edu
Mitchell Rosen, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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