Sperm Preparation Prior to Intrauterine Insemination Study

Not Applicable

Recruiting

• Conditions: Anovulation; Fertility Disorders; Reproductive Issues; Infertility Secondary; Infertility Unexplained; Infertility
• Interventions: Device: Zymot Multi sperm separation device; Other: Density gradient centrifugation

• Registration Number: NCT05693220
• Lead Sponsor: University of California, San Francisco

Brief 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.

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 Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-20
• Study Start: 2023-02-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-03
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zymot sperm separation device	Zymot Multi sperm separation device	Patients will undergo sperm preparation by the Zymot sperm separation device
Density gradient centrifugation	Density gradient centrifugation	Patients will undergo sperm preparation by density gradient centrifugation

Primary Outcome Measures

Name	Time	Method
Cumulative clinical pregnancy rate	3 treatment cycles, an average of 5 months	The clinical pregnancy rate by treatment group over the course of IUI treatment

Trial Locations

Locations (1)

UCSF Center for Reproductive Health; 🇺🇸 San Francisco, California, United States