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NCT05693220 Clinical Trial

Sperm Preparation Prior to Intrauterine Insemination Study

Infertility Clinical Trial

— PIoUS  

Official title:
The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05693220
Other study ID # 22-36913
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2023
Est. completion date December 31, 2025

Study information
Verified date March 2023
Source University of California, San Francisco
Contact Alisha T Tolani, MD
Phone 6282867307
Email alisha.tolani@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 270
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Zymot Multi sperm separation device
Sperm preparation with Zymot Multi sperm preparation device
Other:
• Density gradient centrifugation
Sperm preparation with density gradient centrifugation

Locations
Country Name City State
United States UCSF Center for Reproductive Health San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cumulative clinical pregnancy rate The clinical pregnancy rate by treatment group over the course of IUI treatment 3 treatment cycles, an average of 5 months
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