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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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