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NCT Number: NCT05693220

Sperm Preparation Prior to Intrauterine Insemination Study

This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.

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Key information

Conditions

Infertility Adnexal Diseases Anovulation Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fertility Disorders Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Secondary Infertility Unexplained Ovarian Diseases Reproductive Issues Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Center for Reproductive Health

San Francisco, California, 94158, United States

Location status: Recruiting

Location contact

Alisha T Tolani, MD

CONTACT

[email protected]

628-286-7307

Alisha T Tolani, MD

PRINCIPAL_INVESTIGATOR

Elena Hoskin

CONTACT

[email protected]

Mitchell Rosen, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zymot Multi sperm separation device

Device

Sperm preparation with Zymot Multi sperm preparation device

Density Gradient Centrifugation

Other

Sperm preparation with density gradient centrifugation

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alisha T Tolani, MD

CONTACT

[email protected]

6282867307

Elena Hoskin

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)

Acronym: PIoUS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2023
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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