Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Fertility Disorders; Infertility Unexplained; Infertility; Infertility Secondary; Anovulation; Reproductive Issues

Treatments: Other: Density gradient centrifugation; Device: Zymot Multi sperm separation device

Study type: Interventional

Funder types: Other

Identifiers

NCT05693220

22-36913

Details and patient eligibility

About

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

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups

Density gradient centrifugation

Active Comparator group

Description:

Patients will undergo sperm preparation by density gradient centrifugation

Treatment:

Other: Density gradient centrifugation

Zymot sperm separation device

Active Comparator group

Description:

Patients will undergo sperm preparation by the Zymot sperm separation device

Treatment:

Device: Zymot Multi sperm separation device