Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)

March 30, 2023 updated by: University of California, San Francisco

The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Center for Reproductive Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alisha T Tolani, MD
        • Principal Investigator:
          • Mitchell Rosen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Density gradient centrifugation
Patients will undergo sperm preparation by density gradient centrifugation
Other: Density gradient centrifugation
Sperm preparation with density gradient centrifugation
Active Comparator: Zymot sperm separation device
Patients will undergo sperm preparation by the Zymot sperm separation device
Device: Zymot Multi sperm separation device
Sperm preparation with Zymot Multi sperm preparation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 treatment cycles, an average of 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Mitchell Rosen, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-36913

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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