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Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)

Primary Purpose

Infertility, Infertility Secondary, Infertility Unexplained

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zymot Multi sperm separation device
Density gradient centrifugation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Intrauterine Insemination, Insemination, Fertility, Infertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UCSF Center for Reproductive HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Density gradient centrifugation

Zymot sperm separation device

Arm Description

Patients will undergo sperm preparation by density gradient centrifugation

Patients will undergo sperm preparation by the Zymot sperm separation device

Outcomes

Primary Outcome Measures

Cumulative clinical pregnancy rate
The clinical pregnancy rate by treatment group over the course of IUI treatment

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
March 30, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05693220
Brief Title
Sperm Preparation Prior to Intrauterine Insemination Study
Acronym
PIoUS
Official Title
The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Infertility Secondary, Infertility Unexplained, Anovulation, Fertility Disorders, Reproductive Issues
Keywords
Intrauterine Insemination, Insemination, Fertility, Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Density gradient centrifugation
Arm Type
Active Comparator
Arm Description
Patients will undergo sperm preparation by density gradient centrifugation
Arm Title
Zymot sperm separation device
Arm Type
Active Comparator
Arm Description
Patients will undergo sperm preparation by the Zymot sperm separation device
Intervention Type
Device
Intervention Name(s)
Zymot Multi sperm separation device
Intervention Description
Sperm preparation with Zymot Multi sperm preparation device
Intervention Type
Other
Intervention Name(s)
Density gradient centrifugation
Intervention Description
Sperm preparation with density gradient centrifugation
Primary Outcome Measure Information:
Title
Cumulative clinical pregnancy rate
Description
The clinical pregnancy rate by treatment group over the course of IUI treatment
Time Frame
3 treatment cycles, an average of 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alisha T Tolani, MD
Phone
6282867307
Email
alisha.tolani@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Hoskin
Email
elena.hoskin@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Rosen, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Center for Reproductive Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alisha T Tolani, MD
Phone
628-286-7307
Email
alisha.tolani@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Elena Hoskin
Email
elena.hoskin@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Alisha T Tolani, MD
First Name & Middle Initial & Last Name & Degree
Mitchell Rosen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31543253
Citation
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.
Results Reference
background
PubMed Identifier
30007319
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.
Results Reference
background

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Sperm Preparation Prior to Intrauterine Insemination Study

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